WO2007008666A2 - Compositions and methods for improving vision using adherent thin films - Google Patents

Abstract

A composition and a method for improving a patient's vision. The composition comprises a polymer selected from the group consisting of silicones, fluorinated silicones, perfluorocarbons, fluorinated alcohols, and fluorinated polyethers with or without a solvent. The method comprises applying the composition to at least one surface of a contact lens adapted for insertion into the patient's eye. The polymer, or a combination of the polymer and solvent, produces an adherent thin film with a desired thickness for delivery of the thin film to a surface of a contact lens.

Description

Compositions and Methods for Improving Vision Using Adherent Thin Films

TECHNICAL FIELD OF THE INVENTION

[0001] The present invention relates to contact lens adherent thin film compositions which have improved comfort resulting from reduced dryness, reduced lens deposits, and reduced allergic reaction to lens material; improved cosmetics resulting from reduced redness; and improved vision resulting from improved depth of focus, improved distance acuity and improved near acuity.

BACKGROUND OF THE INVENTION

[0002] It is well known that contact lens wearers experience a variety of problems and complications from contact lens wear, including dry eye, allergic reactions, inflammatory responses, conjunctivitis, limbal neovascularization, pannus (more extensive neovascularization), epithelial abrasion, superficial punctate keratitis, keratitis, corneal ulceration (keratitis with loss of stromal tissue), and tight contact lens syndrome. Nearly twenty-five percent of contact lens wearers stop wearing their lenses due to these difficulties. Some studies show that about fifty percent of contact lens wearers experience bothersome dry eye at some point during the day or evening. [0003] Silicone hydrogels also cause pervaporation, where the high water permeability of the silicone hydrogel lens leads to water vapor permeating through the lens and being lost to the air, with resultant drying of the corneal epithelium. Soft contact lenses sticking to the epithelium is a problem related to water loss through these lenses, but is particularly troublesome with silicone hydrogel lenses. The hydrophobic surface of the silicone hydrogel lens sticks to epithelium preferentially. Some soft contact lenses have hydrophilic or bipolar surfaces. These surfaces attract protein and mucin deposits. Hydrophobic surfaces, like those of silicone hydrogels, attract lipid deposits.

[0004] Commercially available contact lens solutions offer almost no relief for these problems. Being aqueous based, immiscible in an aqueous solution by design, their benefits are limited to moments of hydration and lens surface coating. In clinical use, it is not moments but hours of benefit that are needed. A recent study of the effect of artificial tears on visual performance in normal subjects wearing contact lenses further documents the problems with leading contact lens solutions for this purpose. In that study, three conditions were investigated: (1) without artificial tears added, (2) with Clerz2 (Ciba Vision) instilled, and (3) with Sensitive Eyes (Bausch & Lomb) applied. The results of this study demonstrated that high spatial frequency contrast sensitivity was found to be reduced after tear film break-up and was not enhanced by either tear solution. Accordingly, conventional aqueous contact lens solutions provide poor pre-lens tear film stability. [0005] Soft contact lenses, such as hydrogels, retain the necessary oxygen permeability by being water filled. The water in such lenses includes bonded and nonbonded water. Nonbonded water stays in an equilibrium with aqueous from the ocular epithelium, from the tear film cushion underneath the lens, from the lens itself, from water released at the anterior lens surface, and from the atmosphere.

[0006] When a lens is first inserted after being soaked overnight in soaking solution, the lens is filled as designed with water and has its ideal shape. It is well known that shape retention is necessary for excellent optics, which is why gas permeable and hard contact lenses are known to provide the best acuity when all other variables are similar. When a soft lens is worn, the hydration of any soft contact lens changes quickly. The changes in lens optics with soft contact lens hydration loss are well documented. These changes include change in the radius of curvature of the lens (usually steepening), change in the dioptric power, change in the lens' thickness, and change in the lens' refractive index. All of these changes alter the optics in an undesirable way.

[0007] Many factors serve to cause irritation and reduce visual quality. These factors include the difficulty of maintaining sufficient tears to equal water loss, reduced oxygen permeability as water is lost to the lens, and deposits that accumulate on the lens surface. Soft contact lens deposits include protein, mucin, and lipid deposits. All of these deposits decrease comfort, increase allergic reactions, and create a disturbance in the anterior and posterior tear film stability resulting in increased water loss within the lens to evaporation and reduced night vision due to glare and halo from the distortions of the contact lens shape and diffraction of light by the deposits.

[0008] When the tear film fails to perform its functions of lubrication, oxygenation, and removal of debris, particularly with contact lens wear, symptoms of foreign body sensation (grittiness, scratchiness, sandiness), fatigue, and dryness result. A patient may experience severe pain, especially in the presence of filamentary keratopathy. Loss of the smooth refractive surface of the tear film causes blurred vision, which can vary from blink to blink, accounting for a variable manifest refraction and for complaints of variable vision throughout the day. Surface drying may produce reflex tearing and the misleading complaint of excess tears. Typically, symptoms are worse late in the day, with prolonged use of the eyes (as when the patient reads or watches television), and in conditions of heat, wind, and low humidity (as on the beach or ski slopes). Symptoms that are worse in the morning suggest an associated chronic blepharitis, recurrent corneal epithelial erosion, or exposure keratopathy. Further, symptoms include superficial punctate erosions, corneal filaments, coarse mucus plaques, and epithelial defects.

[0009] As hereinabove noted, most of these symptoms result from the unstable tear film and contact lens changes from water loss. The resulting abnormal ocular surface from epithelial changes due to epithelial water loss and touch to the lens surface further diminish the ability of the ocular surface to respond to environmental challenges. Dry eye, if left untreated, can cause progressive pathological changes in the conjunctival and corneal epithelium. [0010] The tear film in a normal eye consists of a thin (about 6-45 um in thickness) film composed of a mucous layer lying over the corneal epithelium and an aqueous layer covering the mucous layer and epithelium, which is in turn covered by an extremely thin (0.01-0.22 um) layer of lipid molecules.

[0011] The presence of a continuous tear film is important for the well-being of the corneal and conjunctival epithelium and provides the cornea with an optically high quality surface. In addition, the aqueous part of the tear film acts as a lubricant to the eyelids during blinking of the lids. Furthermore, certain enzymes contained in the tear fluid, for example, immunoglobulin A, lysozyme and beta lysin, are known to have bacteriostatic properties. Contact lens wear negatively affects this physiology.

[0012] Taking into account evaporation, the continuous production and drainage of aqueous tear is important to maintaining the corneal and conjunctival epithelium in a moist state, in providing nutrients for epithelian respiration, in supplying bacteriostatic agents and in cleaning the ocular surface by the flushing action of tear movement.

[0013] A key deficiency in dry eye syndromes, or pseudo dry eye syndromes induced by contact lens wear, is reduced protection from evaporation by a reduced or otherwise deficient oil layer. Likewise, improving the protection provided by a layer that reduces aqueous evaporation leads to effectively more tear volume and a prolonged tear break up time, resulting in a more effective and physiologic lubrication of the corneal surface. Clearly, such a lubricant must offer excellent properties of oxygen diffusion as well as reduced aqueous evaporation for greatest efficacy.

[0014] Normally, aqueous-deficient dry eye states, such as, keratoconjunctivitis sicca (KCS), are treated by supplementation of the tears with artificial tear substitutes. However, relief is limited by the retention time of the administered artificial tear solution in the eye. Typically, the effect of an artificial tear solution administered to the eye dissipates within about five to fifteen minutes. The effect of such products, while soothing initially, does not last long enough. The patient is inconvenienced by the necessity of repeated administration of the artificial tear solution in the eye as needed to supplement the normal tears.

[0015] Presently, artificial tear preparations, lens rewetting solutions and ophthalmic lubricants and ointments utilizing active components to provide a thin protective film to reduce evaporation while allowing effective oxygen diffusion are nonexistent. Such available artificial tear solutions commonly include carboxymethyl, methyl or ethyl cellulose or polyvinyl alcohol as the principal active ingredient. Lubricants and ointments tend more toward replacement of oil in the lipid layer of the tear film and commonly include petrolatum, lanolin and/or mineral oil.

[0016] As with artificial tears, contact lens rewetting products vary in composition. The solutions are typically aqueous, buffered solutions which frequently contain carboxymethyl, methyl or ethyl cellulose, polyvinyl alcohol and/or glycerin. There is a growing understanding of the factors involved in the inflammation of the ocular environment and in particular in contact lens wear, where a vast array of contact lens materials are available and it is known that foreign materials can aggravate or modulate the normal host immune response. Spoilation by proteins has the potential to stimulate, mediate or produce excessive immunological reactions. Vitronectin, for example, is an important inflammatory marker which can be detected on the lens surface by means of an on-lens, cell-based assay. The advent of disposable and frequent replacement lenses has not overcome the problems associated with lens-tear interactions. Indeed, the widespread use of high water content, ionic lenses has made the problem more acute.

[0017] Tight Contact Lens Syndrome occurs when a contact lens becomes poorly fitting. Because of a variety of factors, including tear film deficiencies and changes in corneal curvature with contact lens wear, a tight contact lens syndrome may occur even in patients with initially well-fitting contacts. The patient usually complains that the lens feels fine until after a few hours of wear, at which point it becomes uncomfortable. The eye may also become red. The symptoms usually resolve within a few hours after discontinuance of contact lens wear. Tight contact lens syndrome can often be diagnosed by the ophthalmologist with the pertinent history and examination, the latter of which shows a contact lens that scarcely moves on the cornea with blinking. As the aqueous layer between the corneal epithelium and the contact lens becomes reduced, direct contact between the posterior contact lens surface and the anterior epithelium can occur. This results in punctate keratitis, inflammation and irregularity of the epithelial layer that is painful and increases infection risk. Corneal abrasion may result as well. Protein deposition on the contact lens surface results that creates added inflammatory reaction. Such lenses become difficult to remove and vision, particularly at night, becomes dangerously reduced with glare, halo effects, reduced contrast sensitivity, reduced acuity, including that induced by poor centration as the lens tightens.

[0018] Currently, no artificial tear solution or contact lens rewetting solution offers protection from the deleterious effects of uv-a and uv-b radiation. Though many glasses provide such protection, this is not uniform; is not afforded as completely by the unprotected eye; and is not afforded such protection by most contact lens materials.

[0019] Of the available contact lens solutions, none prophylactically improve tear break up time, reduce lens deposits during wear, reduce evaporation and pervaporation, decrease morbidity of epithelial touch, and improve visual acuity at distance and near, all for at least several hours duration to be truly useful to the wearer without need for frequent reapplication.

SUMMARY OF THE INVENTION

[0020] In one aspect, the invention is a method of improving a patient's vision comprising providing a composition comprising a polymer selected from the group consisting of silicones, fluorinated silicones, perfluorocarbons, fluorinated alcohols, and fluorinated polyethers; with or without a highly volatile solvent; and applying the composition to at least one surface of a contact lens for insertion into a patient's eye.

[0021] In another aspect, the invention is a composition for application to at least one surface of a contact lens to improve a patient's vision comprising a polymer selected from the group consisting of silicones, fluorinated silicones, perfluorocarbons, fluorinated alcohols, and fluorinated polyethers; with or without a highly volatile solvent.

[0022] According to one embodiment, the composition comprises about 80% to about 95% polymer. According to another embodiment, the composition comprises about 85% to about 90% polymer. According to another embodiment, the composition comprises about 5% to about 25% solvent. According to another embodiment, the composition comprises about 7.5% to about 15% solvent. According to one embodiment, the composition further comprises an adherent thin film with a desired thickness for delivery of the thin film to a surface of a contact lens.

[0023] According to one embodiment, the polymer comprises dimethicone. According to one embodiment, the dimethicone comprises a viscosity of about 10 to about 20,000 centistokes. According to another embodiment, the dimethicone comprises a viscosity of about 250 to about 15,000 centistokes. According to another embodiment, the dimethicone comprises a viscosity of about 12,500 centistokes.

[0024] According to one embodiment, the polymer comprises a fluoroguerbet. According to one embodiment, the fluoroguerbet comprises a 38 carbon guerbet.

[0025] According to one embodiment, the polymer comprises a fluorine concentration of about 1% to about 10%. According to another embodiment, the polymer comprises a fluorine concentration of about 3% to about 5% [0026] According to one embodiment, the solvent is selected from the group consisting of silicones, fluorinated silicones, perfluorocarbons, fluorinated alcohols, and fluorinated polyethers. According to one embodiment, the solvent comprises cyclomethicone. According to one embodiment, the cyclomethicone comprises a viscosity of about 0.5 to about 5 centistokes. According to another embodiment, the cyclomethicone comprises a viscosity of about 1 to about 4 centistokes. According to one embodiment of the composition, the composition comprises about 75% to 93.5% dimethicone polymer and about 7.5% to 25% solvent.

[0027] According to one embodiment, improved vision comprises improved depth of focus. According to another embodiment, improved vision comprises improved near acuity. According to another embodiment, improved vision comprises improved distance acuity. According to another embodiment improved vision comprises improved quality of vision. According to another embodiment improved vision comprises reduced spherical aberration. According to another embodiment improved vision comprises an improved Strehl ratio and improved optical resolution closer to the diffraction limit. According to another embodiment, improved vision comprises improved contrast sensitivity. According to another embodiment, improved vision comprises improved night vision.

[0028] According to one embodiment, the method further comprises the step of applying the composition to at least one surfact of the contact lens during manufacturing or packaging of the contact lens. According to another embodiment, the method further comprises the step of heat sterilizing the contact lens prior to application of the composition to at least one surface of the contact lens. According to another embodiment, the method further comprises the step of heating the contact lens following application of the composition to at least one surface of the contact lens. According to another embodiment, the method further comprises the step of packaging the contact lens with the composition. According to another embodiment, the method further comprises the step of packaging the composition in a container comprising glass, polypropylene, or epoxy-lined aluminum.

[0029] According to one embodiment, the composition remains on the contact lens following insertion into the patient's eye for at least two hours. According to one embodiment, the composition remains on the contact lens following insertion into the patient's eye for at least four hours. According to one embodiment, the composition remains on the contact lens following insertion into the patient's eye for at least twelve hours. According to one embodiment, the contact lens comprises a daily disposable lens. According to another embodiment, the contact lens comprises a continuous use contact lens. According to another embodiment, the contact lens comprises a daily wear lens. According to another embodiment, the contact lens comprises a planned replacement lens.

[0030] In another aspect, the invention comprises a method of improving a patient's vision comprising the steps of providing a composition comprising at least one polymer selected from the group consisting of silicones, fluorinated silicones, perfluorocarbons, fluorinated alcohols, and fluorinated polyethers, applying the composition to at least one surface of a contact lens for insertion into the patient's eye, and index matching the composition to the contact lens material, wherein the composition further reduces front and back light scatter. [0031] According to one embodiment, the index of refraction of the composition comprises between 1.2 and 1.48. According to another embodiment, the index of refraction of the composition comprises between 1.30 and 1.45. According to another embodiment, the index of refraction of the composition comprises between 1.38 and 1.40.

BRIEF DESCRIPTION OF THE DRAWINGS

[0032] In the following description, various embodiments of the present invention are described with reference to the following drawings, in which:

[0033] FIGS. IA and IB depict results for dryness (IA) and comfort (IB) with and without the composition of the present application according to one embodiment of the invention.

[0034] FIG. 2 depicts results for near and distance visual acuity according to one embodiment of the invention.

[0035] FIG. 3 depicts the angle of incidence of a transmitted light ray at a low angle of incidence.

[0036] FIG. 4 depicts the angle of refraction of a transmitted light ray at a high angle of incidence.

[0037] FIG. 5 depicts the angles of incidence of parallel and divergent rays of light striking an optical surface and resulting spherical aberrations. [0038] FIG. 6 depicts the light intensity profile, left, and airy disc and rings, right, demonstrating spherical aberration affects of the distribution of light intensity across the diffracted airy disc and rings.

[0039] FIGS. 7A, 7B and 7C depict the distribution of light intensity in spherical aberrations. FIG. 7A depicts high spherical aberration, with light intensity distribution concentrated more peripherally. FIG. 7B depicts moderate spherical aberration, with light intensity distribution increasing centrally. FIG. 7C depicts low spherical aberration, with light intensity distribution concentrated more centrally.

[0040] FIG. 8 depicts the relationship between point spread function and spherical aberration.

[0041] FIGS. 9A, 9B, 9C and 9D depict the relationship between the airy disk, its rings, and the ability to resolve two object points adjacent to each other.

DETAILED DESCRIPTION OF THE INVENTION

[0042] Co-owned pending U.S. Patent Application Serial Nos. 11/147,523 and 11/148,052, both filed on June 8, 2005, teach the use of adherent thin films to condition contact lenses. The thin film compositions described include silicones, fluorinated silicones, perfluorcarbons, fluorinated alcohols, fluorinated polyethers and combinations thereof for application to the exterior surface of the eye or for application to the surface of a contact lens prior to insertion into the eye. Each contemplated composition allows for oxygen permeability to the cornea, the production of a hydrophobic seal around the contact lens to reduce evaporation from the lens, enhanced protection of the epithelium from dryness and other environmental factors, and reduced lens deposits. Each of these properties improves the overall comfort of the eye and reduce redness resulting from environmental or contact lens related distress.

[0043] The ideal contact lens conditioning gel, artificial tear, or vehicle for delivery of drugs would have an extended half-life. Conventional contact lens solutions and tears, for example, have half-lives of only minutes. Similarly, aqueous-based artificial tears have half-lives of only minutes. Even nonaqueous compositions rarely last more than a few hours.

[0044] There is great potential clinical benefit for an eye preparation that, when applied, produces a long lasting microfilm that disperses easily, has a low vapor pressure so as to be longer lasting, which is hydrophobic to retard evaporation, and to some extent somewhat viscous, oleophobic, or both, to resist being easily solubilized and washed away by the oil layer or tear film of the eye. The composition should be clear in color to allow sight through the composition when applied either directly to the eye or first applied to a contact lens inserted in the eye. There is a further advantage to such compounds which have oxygen permeability as well.

[0045] Compositions for the purpose of the present invention, which have the desired characteristics, have been created in several embodiments, from several classes of compounds, including silicone compositions, fluorinated silicone compositions, fluorinated alcohols, perfluorocarbons, perfluorinated polyethers, including fomblin z and fomblin z-dol lubricants. [0046] Spectroscopic analysis of contact lens surfaces has demonstrated several impurities, such as silicon, on all contact lens surfaces. These impurities may facilitate Van der Walls type attraction to a variety of gels and or liquids that create an adherent film with desirable properties and thereby optimize contact lens performance. Such desirable properties include maintaining oxygen permeability, sealing the lens surfaces, and inhibiting lens deposits.

[0047] According to one embodiment, the present invention relates to an aqueous and/or nonaqueous silicone polymer composition eye preparation for conditioning the surface of a subject's eye or contact lens. The silicone composition is applied as a thin adherent film on the surface of a subject's eye or on the anterior or posterior or both contact lens surface(s) prior to insertion in a subject's eye to condition the contact lens and relieve symptoms associated with prolonged contact lens wear. The silicone composition is applied directly to the eye of a subject to relieve symptoms associated with dry eye conditions. Alternatively, the silicone composition is applied to the surface of a contact lens. An adherent microfilm of the composition results on the contact lens, for example, by applying the preparation to the lens surface(s), rubbing the lens edges together for a few seconds, and then rinsing with an aqueous solution and rubbing a second time. The silicone composition is a highly oxygen permeable, hydrophobic adherent film.

[0048] According to another embodiment, the present invention relates to a volatile and/or nonvolatile perfluorocarbon polymer composition eye preparation for conditioning the surface of a subject's eye or contact lens. The perfluorocarbon composition is applied as a thin adherent film on the surface of a subject's eye or on the anterior or posterior or both contact lens surface(s) prior to insertion in a subject's eye to condition the contact lens and relieve symptoms associated with prolonged contact lens wear. The perfluorocarbon composition is applied directly to the eye of a subject to relieve symptoms associated with dry eye conditions. The perfluorocarbon composition is a highly oxygen permeable, hydrophobic adherent film and provides similar benefits and mechanisms of action as silicon polymers.

[0049] According to another embodiment, the polymer composition is comprised of a fiuorinated silicone, for example, a perfluorosilicone, a perfluorocarbon, or a perfluoroalkane. Fluorinating silicones and other polymers changes certain properties of the composition, for example, changing the viscosity, spreadability, and/or oleophobicity of the composition. Fiuorinated polymers, for example, perfluorocarbons, perfluorosilicones, such as perfluorononyl dimethicone, and perfluoroalkanes, are oleophobic or insoluble in oil. Such polymers are not diluted or degraded by natural or foreign oils present in the ocular tear film or region, and are therefore able to retain their therapeutic effect within the eye for a longer period of time.

[0050] The polymer composition is in the form of a fluid, a gel, or an emulsion having a viscosity of 1 to 15,000 centistokes. A preferred polymer composition for application as a contact lens conditioning agent has a viscosity of about 300 to about 10,000 centistokes, preferably about 8,000 centistokes. A preferred polymer composition for topical application as a dry eye treatment has a viscosity of about 1 to about 8,000 centistokes, preferably about 200 to 400 centistokes. An emollient, for example but not limited to, docosyl docosanoate, is added to the polymer composition to increase the viscosity of the composition forming a gel or an emulsion. A silicone gum is added to the polymer composition to increase the viscosity of the composition.

[0051] According to one embodiment, the polymer composition comprises one of the following polymers in a substantially pure form: a silicone polymer, a nonaqueous silicone polymer, a perfluorocarbon polymer, a perfluorosilicone polymer, and a perfluoroalkane polymer. According to another embodiment, the polymer composition is a blend of at least two classes of polymers. Alternatively, the polymer composition is a blend of at least two polymers from the same class. Alternatively, the polymer composition is a single polymer blended from at least two viscosities of the polymer.

[0052] According to one embodiment, the polymer composition thin film is delivered directly to the ocular surface, for example, to treat a dry eye condition. One illustrative embodiment combines an aqueous solution with a hydrophobic oxygen permeable polymer composition. A further embodiment results from combining a hypertonic aqueous solution, such as a 0.1% to 10% saline solution, preferably a 0.5% to 2.5% saline solution, with the hydrophobic polymer, such as in an emulsion.

[0053] According to another embodiment, the polymer composition thin film is delivered to an anterior contact lens surface, a posterior contact lens surface, or both the anterior and posterior surfaces of a contact lens. The polymer is applied as a thin film to retard evaporation of the aqueous layer while still providing excellent oxygen diffusion to ocular tissues. According to another embodiment, the polymer composition further forms an aqueous solution used in packaging, storing, shipping, or distributing a contact lens, for example, a daily wear disposable contact lens. Alternatively, the polymer composition is used, either alone or in combination with other aqueous agents, as an overnight storage solution for daily wear contact lenses.

[0054] When the polymer composition thin film is applied to the contact lens, a dramatic improvement in contact lens function, comfort, and vision results. It is contemplated that the polymer composition thin film can be applied in its pure form, as an emulsion with an isotonic aqueous solution, or with immediate sequential application of aqueous solution. The adherent polymer composition reduces lens evaporation and the aqueous solution allows easier elimination of excess polymer. The aqueous solution also assists in providing an increase in the underlying aqueous volume beneath the contact lens, or beneath the polymer composition fluid layer in dry eye subjects. The polymer composition does not easily evaporate, which prolongs retention of this layer, along with the high oxygen diffusion properties of the preferred polymer composition.

[0055] The polymers have a high comfort level and low irritation potential suitable for delivery of medications to sensitive areas such as ocular tissues. Such polymers are well known for their excellent oxygen diffusion capabilities. For example, laboratory mice have been able to survive breathing an enriched silicone oil mixture. Because the surface of all soft contact lenses contain silicone either as an impurity or as part of the manufactured material, the polymer composition thin film binds well to the anterior contact lens surface, providing virtually immediate reduced evaporation with excellent oxygen diffusion. [0056] The use of preinsertion polymer compositions on both sides of a hydrated lens allows for long hours of conditioning benefit that are supplemented by the less viscous topical application of similar polymer compositions to achieve hours of daily conditioning. According to one embodiment, the preinsertion high viscosity gel compositions last, for example, about 10 to 12 hours. According to another embodiment, the topical fluid reconditioning compositions last, for example, about 2 to 4 hours and can be repeated as needed.

[0057] The polymer compositions seal the ocular epithelium, preventing evaporative water loss from the ocular tissue and lubricating the mechanical motion of the eyelid. Unmodified polymers stay on or near the surface of the conjunctiva and corneal epithelium and are excellent lubricants. Not only are the molecules too big to physically enter past the upper living cells — they associate with the upper layer of drying epithelium — but they also cannot penetrate cell membranes due to their large size. The molecules lubricate the surface of the epithelium, relieving the mechanical distress of repeated eyelid motion over the dried epithelium. The molecules also dislike both the water and proteins inside cells, solubilizing lipid deposits and reducing their accumulation on the contact lens surface over time of use.

[0058] Multiple classes of compounds have been found to achieve the desired properties for conditioning the contact lens surfaces, either prior to insertion of the contact lens in the eye or as a topical application with or without contact lens wear. The first class of compounds is nonaqueous silicone polymers, including cyclomethicone, dimethicone, and silicone gums. According to one illustrative embodiment of the invention, a nonaqueous silicone polymer composition contains, for example, dimethicone dissolved in cyclomethicone. This composition is a blend of a high viscosity dimethicone gum and a low viscosity cyclomethicone liquid, resulting in a composition with a viscosity of preferably about 4,000 to 8,000 centistokes. A lower viscosity blend, with a higher relative concentration of cyclomethicone, is rapidly spread and even a small drop will coat the anterior contact lens surface during wear. Application of the lower viscosity composition provides immediate improvement in optics, followed by a continuous, gradual improvement that results as tears continue to reach the undersurface of the contact lens with an anterior surface waterproof seal, and rehydrate the lens.

[0059] Cyclomethicones are unmodified silicones. They evaporate quickly after application, helping to carry oils into the top layer of epidermis. From there, they may be absorbed by the epithelium. Cyclomethicones perform a similar function in hair care products by helping nutrients enter the epithelial keratin protein.

[0060] Dimethicones are also unmodified silicones. They form a barrier layer on the epithelium which must be renewed as the epithelium sloughs off. Dimethicones have been found to coat the surface of the epithelium and lubricate it, providing a function similar to mucin within tear film as well as providing an overlying floating protective layer.

[0061] Silicones form a protective layer which helps prevent transepithelial water loss, a very useful characteristic for dry eye patients as well as for prolonged comfortable and more functional contact lens wear. According to one embodiment, silicone gums add further protective coating. Silicones, including silicone gums, act to help seal moisture into the corneal epithelial keratin matrix.

[0062] According to one embodiment, a range of fluid properties of the polymers are possible by varying the viscosity through combination of various volatile and nonvolatile silicone, perfluorocarbon, perfluorosilicone, fluorinated alcohol or perfluorinated polyether polymers. For example, unmodified silicones are insoluble in water and other polar compounds. However, they will emulsify well using more common emulsifying agents. It is contemplated that all silicone emulsions may be used.

[0063] Silicones can also be modified or changed to improve solubility.

According to one embodiment, silicones are fluorinated to form, for example, perfluorosilicones. The silicones may be fluorinated in a range of about 0.5% to 20%. Fluorinating the silicones improves the oleophobicity of the molecules, resulting in a composition that reduces the concentration of lipid deposits on the conditioned contact lens. Additionally, the improved oleophobicity of the composition increases the duration of therapeutic effect and, accordingly, the duration of comfortable contact lens wear.

[0064] Exemplary perfluorosilicones include perfiuorononyl dimethicone and dimethicone propylethylenediamine behenate. Preferred perfluorosilicones are hydrophobic, oxygen permeable, oleophobic, and have a range of possible viscosities for various topical applications. [0065] Polymer compositions dissolve well in and will dissolve non-polar materials. Non-polar materials include essential oils, mineral oil, fixed oils, light esters, and sunscreen agents. In addition, polymer compositions greatly minimize, if not eliminate, irritation from sunscreen agents, making possible added ultraviolet light (uv) protection over the corneal surface. Solubility decreases, however, as the size and viscosity of the polymer composition increases.

[0066] A second class of compounds is perfluorocarbon polymers, which offer similar properties of hydrophobicity, oxygen permeability, and variation in viscosity as the silicone polymers. In addition, some perfluorocarbons are more hydrophobic and can be used to retard protein and mucin deposits and to absorb the lipid deposits, like the silicone polymers.

[0067] Perfluorocarbons offer many of the same characteristics as the silicones - hydrophobic, highly oxygen permeable, with a greater range of lipophilicity, and may be used as dry eye and contact lens conditioning agents. According to one embodiment, lipophilic perfluorocarbons are preferred. Viscosity can be increased for preinsertion contact lens conditioning gels and less viscous compositions used for topical application to the eye or lens during wear.

[0068] Examples of perfluorocarbons used in preferred embodiments to provide dry eye and/or contact lens conditioning include perfluoromethylcyclohexylpiperidine (PFMCP), perfluorooctyl ethane (PFOE), perflubron (PFOB), perfluorohexyl bromide (PFHB), perfluorooctyl iodide (PFOI), and dibromoperfluorohexane (diBrPFH). According to a preferred embodiment, perfluoro-n-octane is used. [0069] According to one embodiment, derivatives of perfluorocarbons, such as perfluoroalkanes, that are oxygen permeable and hydrophobic are also used to form the composition. Exemplary perfluoroalkanes include perfluorohexylhexane (F6H6) and perfluorohexyloctane (F6H8). Perfluoroalkanes may also be combined with silicone oils, for example, in a ratio of 70% perfluoroalkane to 30% silicone. One exemplary combination is perfluorononyl dimethicone.

[0070] The exemplary perfluorocarbons offer a range of lipid solubilities from nearly insoluble to fairly highly lipid soluble. Perfluoroalkanes may also be combined with emollients, such as docosyl docosanoate, to increase the viscosity of the composition and increase the adherence of the composition to the eye or contact lens.

[0071] Perfluorocarbons are biochemically inert and have been used as blood substitutes. The perfluorocarbons have additional properties which allow their use as an emulsion or allow lipophilic drugs to be carried in the more lipid soluble perfluorocarbons. These agents condition contact lenses and seal the surfaces from water loss to optimize shape retention and reduce deposits.

[0072] A third class of compounds is fluorinated alcohols. Fluorinated alcohols offer similar properties of hydrophobicity, oxygen permeability, and variation in viscosity as the silicone and perfluorocarbon polymers. In addition, some fluorinated alcohols are hydrophobic and can be used to retard protein and mucin deposits and to absorb the lipid deposits, like the silicone and perfluorocarbon polymers. [0073] Exemplary fluorinated alcohols include the perfluoroalkylethanols and omega-perfluoroisopropoxy-perfluoroalkyl ethanols having two to twelve carbon atoms in the perfluoroalkyl groups, as well as the propanol homologues thereof. Most preferred are the perfluoroalkyl ethanols having six to twelve carbon atoms in the perfluoroalkyl groups, and mixture thereof. According to a preferred embodiment, the composition comprises dioctyldodecylfluoroheptyl citrate.

[0074] A fourth class of compounds are perfluorinated polyethers, including Fomblin Z and Fomblin Z-dol lubricants. Fomblins are modified perfluorinated polyethers having the general formula X-(OCF₂)_X-(OCF2 CF₂₎-O-X with x= CF₃ for Fomblin Z; and x =CF₂CH₂OH for Fomblin Z-dol. Polyethylene glycol zdols, polypropylene glycol zdols, or dihydroxy derivatives of perfluoropolyoxyalkane (Fomblin Z DOL, Solvey Solexis, Inc. Thorofare, NJ) are preferred embodiments. Perfluorinated polyethers offer similar properties of hydrophobicity, oxygen permeability, and variation in viscosity as the silicone, perfluorocarbon and fluorinated alcohol polymers.

[0075] Silicones, perfluorosilicones, perfluorocarbons, fluorinated alcohols and perfluorinated polyethers all have properties of hydrophobicity and oxygen permeability that may make them suitable as dry eye and/or contact lens conditioning agents. Fluorinated polymers, for example, perfluorocarbons, perfluorosilicones and perfluoroalkanes, are also oleophobic (they do not dissolve oil). This has advantages for prevention of oil deposits on contact lens surfaces. Perfluorocarbons and other fluorinated polymers also reduce adherence of oils, proteins and other lipids to the surface of the contact lens. [0076] According to another embodiment, the composition comprises a combination of two or more polymers selected from the group consisting of silicones, perfluorosilicones, perfluorocarbons, fluorinated alcohols and perfluorinated polyethers. Combining these polymers confers further advantages for a dry eye and/or contact lens conditioning agent, adding properties such as oleophobicity (oil insolubility) while retaining some silicone properties and promoting better adherence. Examples of such a compound include perfluorononyl dimethicone, with a range of viscosities. Other similar combinations of perfiuorocarbon and silicone are possible. By substituting fluorine in various percentages (ranging from about 1% to at least 20%) into dimethicone, a range of spreadability and oleophobicity is achieved. Viscosities ranging from about 1 to 15,000 centistokes are possible. Lower viscosities allow for topical application during contact lens wear; higher viscosities serve as gels for preinsertion conditioning of contact lens surfaces.

[0077] According to one embodiment of the invention, the polymer composition further comprises a therapeutic agent. According to a preferred embodiment, the therapeutic agent is lipophilic. Exemplary therapeutic agents include an anti- rejection agent such as cyclosporine, an antibiotic, an antimicrobial, a vasoconstrictor, a pupil size management agent, a glaucoma agent, a macular degeneration agent, or an agent to arrest the development of cataracts. Furthermore, the therapeutic agent may be a slow-release composition. [0078] According to one embodiment, the therapeutic agent is cyclosporin, a known anti rejection drug with properties for relieving dry eye. Cyclosporin will not solubilize in an aqueous environment and cannot be carried in an aqueous vehicle. However, silicone polymers, and the more lipophilic perfluorocarbons, can solubilize cyclosporin. Application of an adherent thin film layer of the composition to the surface of the eye or contact lens allows for slow release of cyclosporin to the ocular tissue. Therapeutic release of cyclosporin to ocular tissue over time further minimizes the inflammatory reaction and treats dry eye more potently.

[0079] According to another embodiment of the invention, the therapeutic agent is an anti-infective. Anti-infectives include, but are not limited to, antibacterial agents, , antifungal agents, antimycobacterial agents, antiparasitic agents, antiviral agents, and vaccines. Examples of anti-infectives include, but are not limited to, polymoxin B, bacitracin, sulfacetamide, erythromycin, fluoroquinolones, levofloxacin, neomycin, tobramycin, vancomycin, aminoglycosides, ciprofloxacin, norfloxacin, oflaxacin, amphoB, fluconazole, chlorhexidine, natamycin, acyclovir, and trifluridine.

[0080] According to another embodiment of the invention, the therapeutic agent is a vasoconstrictor. It is desireable when wearing contact lenses to minimize vasodilation and redness. However, alpha agonist vasoconstrictors, normally used topically to reduce redness, are not medically safe when soft contact lenses are worn. The free water within a soft contact lens acts as a reservoir and can significantly increase the concentration of alpha agonist delivered to the eye. Rebound redness is a known problem of topical alpha agonists when concentrations that are too high are delivered, or when repeat exposure more than once or twice a day results.

[0081] The conditioning agents of the present invention result in a waterproof seal of the lens surface(s). Topical vasoconstrictors, for example, oxymetazoline, can be used with soft contact lenses treated with the composition of the present invention without undue risk, since the vasoconstrictor will not be taken up in the now sealed contact lens. Additional exemplary vasoconstrictors include, but are not limited to, epinephrine, norepinephrine, levonordefrin, amphetamine, methamphetamine, hydroxyamphetamine, ephedrine, phenylephrine, isoproterenol, dopamine, methoxamine, tyramine, and metaraminol.

[0082] According to another embodiment of the invention, the therapeutic agent is a pupil size management agent. Pupil size management agents include, but are not limited to, alpha- 1 antagonists, which include imidazoline, phentolamine, and phenoxybenzamine; cholinergic agents; and alpha-2 agonists. As used in the present application, alpha 1 antagonist refers to any agent that binds to the alpha 1 adrenergic receptor, which includes alpha 1 adrenergic receptor antagonists. Preferably, the alpha 1 adrenergic antagonist is iris smooth muscle dilator selective. More preferably, the alpha 1 antagonist is in the phentolamine family, known as imidazolines, an alkylating agent such as phenoxybenzamine, or a piperazinyl quinazoline with more potent alpha- 1 adrenergic antagonist activity than dapiperazole. Most preferably, the alpha 1 antagonist is phentolamine or phenoxybenzamine, but any alpha 1 antagonist can be used in the present invention. Cholinergic agents include, but are not limited to, pilocarpine and aceclidine. Alpha-2 agonists include, but are not limited to, brimonidine. Pupil size management agents are described in more detail in U.S. Patent Numbers 6,291,498, 6,420,407, 6,515,006, and 6,730,065 to common inventor, Gerald Horn, whose teachings are incorporated by reference in their entirety.

[0083] According to another embodiment of the invention, the therapeutic agent is an agent to treat glaucoma. Glaucoma therapeutic agents include, but are not limited to, beta-blockers, prostaglandin analogs, alpha-agonists, carbonic anhydrase inhibitors, and cholinergic agents.

[0084] According to another embodiment, the therapeutic agent is an agent to treat macular degeneration. Macular degeneration therapeutic agents include, but are not limited to, antioxidants such as vitamin C, vitamin E and beta-carotene, zinc, and copper, and pharmaceuticals such as verteporfin (Visudyne; Novartis Pharmaceuticals Corp.) and pegaptanib sodium (Macugen; Eyetech Pharmaceuticals, Inc. and Pfizer Ophthalmics).

[0085] According to another embodiment, the therapeutic agents is an agent to treat allergic conjunctivitis. Allergic conjunctivitis therapeutic agents include, but are not limited to, cromolyn, lodoxamide, olopatadine, antihistamines such as emedastine and levocabastine, corticosteroids, and inflammatory mediators such as azelastine, nedocromil and pemirolast.

[0086] Additional exemplary therapeutic agents, such as indomethacin and steroids such as androgens, prednisolone, prednisolone acetate, fluorometholone, and dexamethasones, may also be solubilized within the polymer composition with similar low irritation potential. [0087] According to one embodiment of the invention, the polymer composition fUrther contains solubilized fatty acids. The essential fatty acids include, for example, castor oil, corn oil, sunflower oil or light mineral oil, tocopheryl, and soluble forms of vitamin C. These additives offer improved tear film function.

[0088] According to one embodiment of the invention, the polymer composition further comprises a sunscreen. UVA and UVB sunscreen agents, for example but not limited to, oxybenzone, ethylhexyl methoxycinnamate, p-t-butyl p- methoxydibenzoylmethane, avobenzone, oxybenzone, octyl salicylate, octocrylene and octyl p-methoxycinnamate are solubilized in the polymer composition. Sunscreen dissolved in polymer composition is nonirritating and affords improved uv protection to the eye.

[0089] Using current ocular therapeutic agent delivery methods, when a drop of the polymer compound further comprising a therapeutic agent is applied, the blink mechanism and slow corneal absorption renders only a very small fraction of the therapeutic agent within that drop available for intraocular or surface retention.

When such therapeutic agents are added to the polymer composition gels or topicals, the therapeutic agents slow release from the adherent films and increase the availability of such therapeutic agents.

[0090] While it is well known that aqueous compounds can be soaked into a contact lens for slow release, the present invention allows for embodiments with slow release of nonaqueous compounds on the adherent surface film while optimizing contact lens performance and minimizing the amount of a therapeutic agent necessary to treat a dry eye. Further, the volume of a therapeutic agent dissolved within the polymer composition is better controlled than with the high available water volume used by depot absorption of a therapeutic agent into a soft contact lens.

[0091] According to one embodiment of the invention, the polymer composition is adapted to treat a defect of an ocular epithelium, for example, the corneal epithelium or the stroma. Many types of eye surgery require delivery of therapeutic agents and protection of disrupted corneal epithelium and/or stroma. Surface ablation in laser eye surgery, including but not limited to photorefractive keratectomy (PRK), laser- assisted in situ keratomileusis (LASIK) and IntraLase LASIK, other types of eye surgery, including but not limited to cataract surgery using corneal incisions, corneal transplant surgery and glaucoma filtration surgery, epithelial abrasion, epithelial trauma, and any other cause of an epithelial defect requiring protection from further disruption. According to one embodiment, the polymer composition is applied to the surface of the eye, either with or without a protective contact lens, to seal the ocular or corneal epithelium from disruption. According to an alternative embodiment, the polymer composition further includes a therapeutic agent, for example, an antibiotic, to protect and to treat the defective or damaged ocular epithelium. Delivery of therapeutic agents within a silicone polymer, perfluorocarbon polymer, fluorinated alcohol, fluorinated silicon polymer, and/or perfluorinated polyether both protects the disrupted ocular tissue and provides therapeutic agents to treat the defective or damaged epithelium. [0092] Laser eye surgery procedures are particularly well suited for treatment according to the invention. Current laser eye surgery art requires placement of a protective contact lens over the procedure created defect. Such lenses reduce oxygen permeability. A silicone polymer, perfluorocarbon polymer, fluorinated alcohol, fluorinated silicon polymer, and/or perfluorinated polyether retains oxygen permeability while acting as a protective bandage to cover the defect. Depending on the viscosity and oleophobicity of the selected polymer and/or combination of polymers, the polymer composition can obtain a long half-life, and maintain sealant protection of the treated epithelium. According to an alternative embodiment, the polymer composition further includes a therapeutic agent, such as an antibiotic, to treat the damaged epithelium during healing.

[0093] The hydrophobic nature of such conditioning agents minimizes protein and mucin deposition. Lipophilic preferred embodiments also solubilize many lipids that otherwise would deposit on the contact lens surface.

Clinical Studies

[0094] A first clinical evaluation was conducted to evaluate the therapeutic effects of applying a hydrophobic composition to the surface of a contact lens inserted into a subject's eye. A silicone polymer gel composition, consisting of a blend of dimethicone and cyclomethicone, was provided to twenty subjects. The composition is a blend of one low viscosity silicone polymer and one high viscosity silicone polymer, resulting in a blended composition for application to the contact lens surface with a viscosity of about 8,000 centistokes. [0095] Twenty subjects administered the blended silicone polymer gel composition to both the anterior and posterior surfaces of one contact lens and inserted the conditioned contact lens into the subject's right eye. An unconditioned contact lens was inserted into the subject's left eye. Both the right and left eye of each subject were monitored at baseline and at 2, 6, and 10 hours for one day for a thread test, tear break up time, comfort, glare, vision quality, dryness, lens fit, lens comfort, and ease of lens removal. All tests were performed using techniques known in the art. In this study, trends for improvement in the thread test and tear break up time were noted. Figure IA depicts results for dryness with and without the composition of the present application as reported in this trial. Figure IB depicts results for comfort with and without the composition of the present application as reported in this trial. Significant improvement in comfort and dryness were noted.

[0096] In a separate study, tear break up time testing demonstrated an increase in TBU of 20-35% following administration of the blended silicone polymer composition.

[0097] In a separate study, vision quality improved dramatically within 30- 120 seconds of instillation of the blended silicone polymer; but improved even more dramatically after sequential instillation of isotonic aqueous saline. In less than 5 seconds, subjects experienced greater resolution, and greater ability to visualize point light sources with loss of previously seen glare and halo. The effect was prolonged, lasting an average of 4-8 hours following insertion of the conditioned contact lens. [0098] In a separate study, contact lens removal was facilitated by the silicone polymer alone and or silicone polymer /aqueous solution combination. In cases where a daily wear contact lens inadvertently was slept in, removal of the lens remained a matter of a simple sliding of the lens and a pinching out of the eye; whereas in the same individual without the silicone polymer having been previously applied, removal was extremely difficult in all such situations due to tight adherence of the lens to the corneal epithelium.

[0099] A clinical evaluation was conducted to determine the effect on near and distance high and low contrast visual acuity of applying a silicone polymer gel composition to the surface of contact lenses inserted into subjects' eyes. This silicone polymer gel composition, consisting of a specific blend of dimethicone and cyclomethicone, was provided to twenty subjects. The composition is a blend of one low viscosity silicone polymer and one high viscosity silicone polymer, resulting in a blended composition for application to the contact lens surface.

[0100] The near and distance low and high contrast visual acuity of twenty subjects wearing new, single focus correction soft contact lenses was tested. Then the lenses were removed and the blended silicone polymer gel composition was applied to both the anterior and posterior surfaces of each contact lens and reinserted into the subjects' eyes. After waiting 10 minutes, the low and high contrast near and distance visual acuity were tested again. These tests were performed using techniques known in the art. In this study, statistically significant improvements in high and low contrast distance acuity and high contrast near acuity were noted. Figure 2 depicts the results of change in near and distance visual acuity tests of this study. A trend for improvement in low contrast near acuity was noted.

Improved Vision Using Adherent Thin Films

[0101] It has now been discovered that certain compositions comprised of the previously described silicones, fluorinated silicones, perfluorcarbons, fluorinated alcohols, fluorinated polyethers and combinations thereof, when, formulated and combined to produce certain highly desirable viscosities and adherent film thicknesses, are able to alter the effects of light diffraction sufficiently to improve depth of focus, quality of vision, and to improve distance and near vision when the adherent thin films are applied to the surface of a contact lens prior to insertion of the lens in the eye. This effect is surprising, in part, because the effect is long lasting following an initial application of the thin film, and because no improvement in diffraction or refraction of light with thin films applied to contact lenses has been known to occur heretofor. Moreover, the results of clinical experimentation, described in detail below, indicate that the improvement in the depth of focus and near vision may be dependent upon the specific composition used. For example, the equilibrated thickness of the adherent thin film on the contact lens may be a function of the polymer itself, the percentage of solvent in the composition, or the viscosity of the composition. This thin film thickness is similar to the variability of paint thickness as applied, which may vary depending on the pigments used, the amount of solvent within which the pigments are mixed, and the viscosity of the paint. [0102] All contact lenses exhibit light scatter, which can be particularly annoying and even visually disabling at night. Light scatter, including backscatter, is commonly caused by optical aberrations within the surface of the contact lens, deposits of mucin and other proteins on the lens surface, inhomogeneities, and the fundamental properties of light reflectance at boundaries of different indices. In particular, light reflecting off the anterior lens surface, light reflecting off the posterior lens surface, and light reflecting off the anterior corneal surface scatter light and cause unwanted glare, halo, starburst, reduced contrast and other disturbing visual phenomena that degrade the visual image.

[0103] Visual performance, particularly at distance, is very sensitive to tear film stability. Wavefront aberrations increase as the tear film destabilizes and breaks up. Reduced surface tension resulting from the adherent thin films of the present invention stabilizes the tear film. According to one embodiment, a blend of cyclomethicone solvent with dimethicone, has been shown to increase the tear break up time in some individuals by as much as 200%, reducing the frequency and extent of undesireable tear film induced aberrations.

[0104] Spectacle lenses, which are in contact with air on either side, air having an index of refraction of 1.0, have similar reflectance problems. In the case of spectacle lenses, antireflective coatings applied to the anterior and posterior lens surfaces can reduce unwanted light scatter and reflection. In theory, a material of index equal to the square root of the index of the optical material is ideal, at a thickness typically equal to one-quarter the wavelength of light. A material with these properties produces near ideal destructive interference of light at the anterior surface of the coating and reflected light from its posterior surface. For example, glass has an index of about 1.5, and the ideal coating would have an index of about 1.2. However, transparent low index materials are difficult to develop. Magnesium fluoride, with an index of 1.38 is typically used. According to one embodiment, the composition of this invention is a biocompatible material that can be applied to the exterior surface of a contact lens to index match to create an antireflective thin film on the surface of the contact lens.

[0105] The range of contact lens refractive indices must be considered. For most lenses, the index is generally in a range of about 1.43-1.48, slightly less for very high water content lenses. Index matching requires the introduction of a material with an index less than that of the optical material, preferably closer to its square root. While tears have a refractive index of about 1.38, the normal tear film thickness of 2 microns or greater is too thick to allow for antireflective properties, and too inhomogeneous.

[0106] According to one embodiment, silicone gels can be applied to the surface of a contact lens to index match. With an index of 1.40, silicone gels provided a homogenous thin film of less than 1 micron and can be maintained on the lens surface for a clinically significant period of time. According to another embodiment, fluorinated molecules, including fluorinated silicones, can be applied to the surface of a contact lens to index match. Fluorinated molecules exhibit a reduction in refractive index as the fluorine concentration is increased. Fluorinated alcohols have refractive indices of about 1.35 to 1.38, depending on the percent fluorination. For example, 3.5% fluorine exhibits a refractive index of about 1.38. A fluorinated alcohol gel, such as those previously described, produces a very thin film, is long lasting, and very stable. A very thin tear film layer also results from the dramatic decrease in wetting angle on the contact lens surface.

[0107] According to another embodiment, sol-gels can be applied to the surface of a contact lens to index match. Sol-gels are thin films containing homogenous pores, wherein each pore is on a scale approaching the wavelength of light, typically in the range of about 50 to 100 nm. These porous materials serve to effectively reduce the index and obtain a more ideal index match. According to one embodiment, the sol- gel is a dioctyldodecyl fluoroheptyl citrate, an emollient ester with fluorine molecules retained within the material. This composition provides a microporous homogeneous structure with excellent spreadability characteristics. The microporous nature of the material effectively reduces the index of refraction when applied to a contact lens surface as well.

[0108] Further, as thin films approach molecular layer thickness ranges — well under 1 micron — their viscosity effectively increases. For very thin films, a longer adherence time on a contact lens surface is possible, as found with compositions such as the embodiment dioctyldodecyl fluoroheptyl citrate.

[0109] The result is the development of novel thin film gels that can provide more stable tear films with improved wavefronts, and anti-reflective coatings to the anterior surface of a contact lens, while retaining conditioning properties also described above and in previous patent applications. Improved Depth of Focus and Near Vision Using Adherent Thin Films

[0110] The practical difference between distance and near vision is about 50 cm. That is, an object one meter away from the eye is said to provide incident rays of parallel light and is treated via distance nonaccommodated optics for emmetropic focus. Normal reading vision is about 50 cm away, or slightly less, and requires accommodation. Any slight improvement in depth of field that reduces the nonaccommodated image degradation to less than one meter effectively extends the range of emmetropic focus into what is traditionally considered optics that require accommodation, or near focus. This is particularly relevant to presbyopia, where individuals can no longer maintain such focus, or are unable to do so for very long periods of time. An object near, or less than one meter away, has divergent rays of light rather than parallel ones incident to the cornea.

[0111] It is a well known property of antireflective coatings that light rays normal to the coating (such as distance object rays) can have reduced reflectance of the anterior coated surface through destructive interference. However, the effects on light rays of higher angles of incidence becomes potentially relevant with contact lens wear and antireflective thin film coatings. Referring to Figure 3, the transmitted light ray undergoes almost no change in angle of refraction from light at normal or near normal incidence (low angle of incidence). Referring to Figure 4, a considerable change in angle of refraction of the light of high angle of incidence. Current antireflective coatings applied to spectacle lenses do not produce a resultant accommodative benefit from this additional refraction because the exit of the ray from the lens index to air causes a neutralizing reverse effect. [0112] In spectacle lenses coated with an antireflective coating, the rays travel from the air to the antireflective coating to glass or plastic lens to antireflective coating to air. This light travels a path through the following indices: from 1.0 to 1.38 to 1.5 to 1.38 to 1.0.

[0113] In a contact lens, in contrast, the light rays travel from air to a combination tear film / antireflective coating to the cornea to the intraocular fluids. This light travels a path through the following indices: from 1.0 to 1.38 to 1.46 to 1.38. There is a greater index change of the entering light ray than that being transmitted through the antireflective coating. This index change effectively allows light rays of higher angles of incidence to undergo more refraction than those of lower angles of incidence. In other words, distance parallel light rays undergo no such additional refraction. Near objects (defined as less than one meter from eye objects), on the other hand, undergo additional refraction of these rays relative to distance rays. The result is maintained emmetropic focus for objects less than one meter away, traditionally requiring accommodation. There is a slight but clinically significant pseudoaccommodative benefit from the increased depth of focus that a material such as an antireflective coating provides.

[0114] Index matching via the gel means the refracted ray moves closer to the normal drawn through the optic surface. For parallel rays of light striking tangentially, there is no significant change. For divergent rays of light, an improved accommodative focus may occur, as described above. Such light rays, when striking an optical surface at an angle of incidence other than perpendicular, result in spherical aberration. This effect is more pronounced as the distance from the lens center increases, with peripheral light rays striking the lens tangentially refracted in front of, or anterior to, the light rays central to it. This principle is depicted in FIG. 5.

[0115] Index matched rays of light at higher angles of incidence will be refracted closer to the normal, decreasing the spherical aberration. To achieve clinical benefit, this effect is thickness dependent: too thin a film will have no clinical effect and too thick a film will change the refraction of the rays too severely.

[0116] Spherical aberration is a very large source of image degradation. Spherical aberration relates to changes in intensity of light distribution in the diffraction limited focal point, defined by the point spread function. Alternatively this can be seen to relate to light distribution in the central as compared to the peripheral rings of diffracted light that represents the diffraction limited result of focus through any circular aperture, as in focusing into the eye. .

[0117] Technically, each object focused through an aperture results in diffraction limited effects that create a pattern known as a central Airy disk, and peripheral to that, Airy rings, as demonstrated in FIGS. 6, 7A, 7B and 7C. FIG. 6 depicts the light intensity profile, left, and airy disc and rings, right, demonstrating spherical aberration affects of the distribution of light intensity across the diffracted airy disc and rings. FIG. 7A depicts high spherical aberration, with light intensity distribution concentrated more peripherally. FIG. 7B depicts moderate spherical aberration, with light intensity distribution increasing centrally. FIG. 7C depicts low spherical aberration, with light intensity distribution concentrated more centrally. [0118] Accordingly, there is a relationship between the point spread function (PSF), a measure of how tightly an object is focused to a point, and intensity of the point spread function peak as compared to the spherical aberration, with greater intensity peaks for reduced spherical aberration, as illustrated in FIG. 8. FIG. 8 depicts the relationship between PSF and spherical aberration, with high spherical aberration on the left, low spherical aberration on the right, and an increase in peak intensity of PSF with low spherical aberration.

[0119] The increase in intensity is measured as an improved value in the Strehl ratio, which is a measure of how close to the diffraction limit two adjacent objects can be resolved. 1.0 represents a theoretical ideal diffraction limited focus.

Decreasing the spherical aberrations via the polymer composition improves the intensity of the PSF via more light distributed to the central disk and allows resolution of detail previously not resolvable - that is, improves the Strehl ratio closer to the ideal diffraction limit. In this manner, depth of focus can be increased, and near objects that are imperfectly focused in a presbyope will have improved resolving power after application of the composition of the present invention to the contact lens.

[0120] There is a relationship between the airy disk, its rings, and the ability to resolve two object points adjacent to each other. If the two objects are less than Vz radius apart, for example, the image is not resolvable. If there are significant spherical aberrations, the reduced central airy disk light intensity may render the adjacent images unresolvable as well. Figures 9 A, 9B 9C and 9D demonstrate this point. With respect to FIG. 9A, with high spherical aberrations, resolution is reduced to much less than the diffraction limit (reduced Strehl ratio). FIG. 9B illustrates the effect of adjacent viewed objects and the resulting inability to resolve the individual images. However, with application of the composition of the present application, spherical aberration is corrected. Correction of spherical aberration, as illustrated in FIG. 9C, includes a redistribution of light such that less light intensity is focused within the airy rings, and more within the central disk. In the left portion of FIG. 9C, the composition is not present, resulting in increased spherical aberration. In the right portion of FIG. 9C, the composition is present, resulting in a redistribution of light and decreased spherical aberration. FIG. 9D illustrates the correction of spherical aberration of adjacent viewed objects. In the left portion of FIG. 9D, the composition is not present, resulting in increased spherical aberration. In the right portion of FIG. 9D, the composition is present, resulting in an improved ability to resolve the individual images. Spherical aberrations increase with scotopic and mesopic lighting conditions. The application of the composition improves night vision and dim light vision, including contrast sensitivity

[0121] All adherent compositions of the present invention have large molecular spacing, allowing oxygen to permeate. At a critical thickness, the overlap of these large spaces can induce a novel effect reducing the normal effects of diffraction on light, with reduced airy ring size. Just as is known to occur in applications in astronomy, reducing such diffraction effects improves resolution. Similarly, components of letters at near distance normally not resolvable in a presbyope may become resolvable with reduced diffraction effects. [0122] According to another clinical study, two 52 year old contact lens wearers were measured for their near acuity with and without application of a composition comprised primarily of dioctyldodecyl fluoroheptyl citrate. Subject 2 had a mild monovision contact lens correction, but still underwent a similar improvement in near vision. In both cases the test object was held at arms length, about 18 inches from the eye.

TABLE 1

[0123] The closer you are to two objects, the greater the angular separation between them. Up close, two objects are easily resolved. As your distance from the objects increases, their images become less well resolved and the images eventually merge into one image. The resolving power of an optical instrument is its ability to separate the images of two objects, which are close together. Within the eye, the merging of the images is caused by diffraction. The extent of the diffraction, and therefore the ability or inability to resolve multiple images, depends on the size of the aperture, (i.e. the size of the slit). The aperture of your eye is your pupil. According to the theory of diffraction, only a tiny amount of light can pass through a hole that is narrower than the wavelength of the light. Also, the light that is transmitted is diffracted in all directions. [0124] Any reduction in interference pattern formation on the retina can potentially improve the resolution of the eye. The micropores within the composition of the invention offer new potential in this regard, possibly providing a micro pinhole effect. Additionally, the composition can also assist plasmon formation at the surface of the thin film, hi this case, micropores structures

"squeeze" rays of light through smaller apertures, creating a micro-pinhole effect. The light emerges from the aperture as a tightly focused beam that can propagate with very little divergence. The light exiting the aperture, to be resolved by the eye, is now coherent (not diffraction limited), and the depth of field is improved.

[0125] According to another clinical study, a two patient study was conducted using a control, three different compositions of a cyclomethicone/dimethicone mixture and a fluoroguerbet. A technician prepared CIBA Vision Focus Daily contact lenses with the control or one of the active compositions, using the rub and rinse technique. The lenses were then provided to the patient for installation. Following installation, the patients' distance and near vision (two points, 16 and 24 inches) were measured. The patients and the observing optometrist were masked as to the treatment of the lens for each observation. The results of that study follow in Table 2.

TABLE 2

[0126] The results of the second clinical trial indicate that the cyclomethicone/dimethicone blends caused an observable improvement in near vision measured at both 16 and 24 inches, with the lowest cyclomethicone composition tested (10%) providing the best result, a two plus line improvement in reading vision.

[0127] A further clinical evaluation was conducted to evaluate the surface aberrations on a single patient wearing contact lenses with and without the composition. Wavefront mapping was conducted of the lens before and after application of the composition to the surface of the contact lens, inserted into the patient's eye. The results, illustrated in Tables 3, 4, and 5, indicate that application of the composition to the surface of the contact lens significantly reduces spherical aberration. Table 3 indicates the results of wavefront mapping of a -5.0 Ciba Daily lens without the compositon. Table 4 indicates the results of wavefront mapping of a -5.0 Ciba Daily lens with the compositon of the present application applied.

TABLE 3

Range: -20.0 to +20.0 minutes of arc

TABLE 4

Preferred Compositions

[0128] Preferred compositions produce a minimum amount of redness, a maximum quantitative and duration comfort score, a maximum qualitative and duration presbyopic vision correction effect, and a maximum qualitative and duration distance vision correction effect. Table 5 indicates the results of various compositions containing varying percentages of cyclomethicone or dimethicone. The results, as reported in Table 5, indicate that compositions containing between 5% to 20% cyclomethicone in combination with dimethicone produced moderate improvement in visual performance as well as improved comfort and wearability. The mixtures containing the most ideal set of clinical properties are highlighted in bold.

TABLE 5

Q= qualitative; D= quantitative (duration) [0129] Silicones, fluorinated silicones, perfluorocarbons, fluorinated alcohols, perfluorinated polyethers and combinations thereof, which have a relatively high viscosity, can be combined with a solvent having a low viscosity and high volatility to arrive at a desired viscosity. According to one embodiment, the composition is a blend of two silicones, one highly viscous with high molecular weight, and the other very low viscosity, blended to produce a composition with a desired viscosity. The low viscosity silicone acts as a solvent for the high viscosity silicone. According to one embodiment, the composition comprises a high viscosity dimethicone and a low viscosity cyclomethicone. According to one embodiment, the two silicones are combined and vigorously agitated to produce a blend. When effectively agitated, the composition produces an adherent thin film that can be applied to the surface of a contact lens.

[0130] The polymer solvent combination can be applied to the surface of a soft contact lens to enhance the performance characteristics of the lens. A preferred combination comprises a range of about 5% to about 25% solvent, a range of percentage of solvent producing a thin film with a viscosity shown to improve visual performance in terms of both distance and near vision acuity, contrast sensitivity, depth perception, depth of focus, and enhancement of the overall quality of vision.

[0131] According to one embodiment, the low viscosity silicone, the solvent, is cyclomethicone. Cyclomethicone is a highly volatile solvent, which, when used as a carrier, means that the material has a measurable vapor pressure. As such, cyclomethicone will form a combination with dimethicone having a viscosity in a range from about 10 centistokes to about 20,000 centistokes, preferably about 12,500 centistokes. As the percentage of cyclomethicone within the combination decreases, the viscosity of the overall mixture increases. A combination with a cyclomethicone percentage ranging from about 75% down to about 20% produces a thin film with high comfort, but with little effect on vision. A combination with a cyclomethicone percentage at about 25% to about 5% has been shown to improve visual performance, measured in terms of quality of vision, improved depth of focus, and quantifiable acuity measured at both distance and near. Combinations containing only about 5% cyclomethicone show diminished comfort and vision benefits, with a total loss of visual performance and comfort benefit when the thin film contains 0% cyclomethicone and 100% dimethicone.

[0132] Based on the results of the clinical study, discussed above, particular compositions produced the desired results in terms of both comfort and vision. To improve comfort, a cyclomethicone percentage in the range of about 5% to about 80% is preferred; to reduce redness, a range of about 7.5% to about 80% cyclomethicone is preferred; to improve presbyopic effect, a range of about 5% to about 25% cyclomethicone is preferred; to improve presbyopic duration, a range of about 7.5% to about 25% cyclomethicone is preferred; to improve distance acuity, a range of about 5% to about 80% cyclomethicone is preferred; and to improve the duration of distance improvement, a range of about 5% to about 80% cyclomethicone is preferred. Based on the findings of the clinical study, the preferred composition for minimizing redness and for maximizing comfort, distance and near acuity is a composition with a cyclomethicone concentration in the range of about 7.5% to about 25%, with a range of about 7.5% to about 12% cyclomethicone being the most preferred embodiment. [0133] According to a preferred embodiment, the composition comprises a blend of about 5% to 25% by weight cyclomethicone with a viscosity of about 4 centistokes and about 75% to 95% by weight dimethicone with a viscosity of about 12,500 centistokes. According to a more preferred embodiment, the composition comprises a blend of about 7.5% to 25% by weight cyclomethicone with a viscosity of about 4 centistokes and about 75% to 93.5% by weight dimethicone with a viscosity of about 12,500 centistokes.

[0134] According to another embodiment, the preferred carrier is a volatile silicone having a boiling point in the range of about 99 degree Celsius to about 260 degree Celsius, a CFS of about 1 to 20, and a solubility in water of less than about 0.1%. According to a preferred embodiment, the carrier is cyclomethicone. The degree of substitution on the siloxane carrier (higher substitution produces a composition with lower solubility) affects the polymer's solubility. The silicones may be either cyclic or linear polydimethyl siloxanes. The number of silicon atoms in the cyclic silicones is about 3 to about 7, most preferably 4 or 5. The general formula for the cyclic silicones is:

CH₃ [Si-O]_n CH₃ wherein n=3-7.

Viscosities are generally less than 10 centipoise (cP) at 25 degree Celsius.

[0135] According to one embodiment, linear polydimethyl siloxanes generally have a viscosity of less than about 5 cP at 25 degree Celsius. The linear volatile silicones contain from about 3 to about 9 silicone atoms and have the general formula (CHa)₃ Si-O-[Si(CHa)₂ O]_n Si(CH ₃)₃ wherein n=l-7.

Silicones of the above described types are widely available e.g., from Dow Corning as 344,345 and 200 fluids; Union Carbide as Silicone 7202 and 7158, and Stauffer Chemical as S WS-03314.

[0136] According to another embodiment, volatile hydrocarbons are used as carriers in the thin film combinations. These hydrocarbons may include straight chain and branched hydrocarbons and may contain from about 10 to about 16 carbon atoms, preferably from about 12 to about 16 carbon atoms.

[0137] According to another embodiment, short chain alcohols such as ethanol are used as solvents to produce the present compositions. Water is not useful in compositions of the present invention either alone or in mixtures with other volatile carriers.

Application of the Film

[0138] According to a preferred embodiment, both surfaces of a contact lens are coated with the thin film of the composition prior to insertion of the lens into the eye. Each surface treated with a thin film coating confers additional advantages. Treatment of the inner surface provides added comfort with decreased morbidity from epithelial touch, and longer retention of tear film thickness between the inner contact lens surface and the corneal epithelium. Treatment of the outer surface results in longer tear break up time, improved vision at both distance and near, as well as improved depth of focus. Treatment of either surface provides a decrease in the quantity of evaporation, pervaporation and lens deposits of aqueous and mucin, both of which create a hydrophobic film on the lens surface, and deposits of lipid, which slowly dissolve the viscous thin film.

[0139] According to one embodiment of the invention, the thin film composition is applied to the contact lens surface during or directly following the contact lens manufacturing process, prior to the packaging and distribution of the contact lens. According to this embodiment, the contact lens has an adherent thin film polymer layer on at least one surface of the contact lens at the time of purchase or use of the contact lens. This embodiment has the benefit of having the thin film polymer adherent layer already applied to the contact lens surface so that the contact lens wearer does not have to condition the lens with the composition prior to insertion of the lens into the eye.

[0140] It is known that for certain polymers, including silicones and blends of silicones, a heating process will cause the polymer to become more intimately associated with the substrate, in this case, the surface of the contact lens. A chemical bond does not result, but rather a strong physical attraction between the surface of the contact lens and the composition results. This physical attraction may be of sufficient strength to maintain this thin film on the contact lens for a few days, several days, a week, several weeks, or even one month or longer during use by a contact lens wearer. Also, heat energy applied during the application process assists small aggregates or droplets of the composition to spread out evenly over the surface and create a more uniform film. The heating process may also assist in creating the desired film thickness of the adherent polymer. 2006/026523

[0141] The process of applying the adherent thin film to the surface of the contact lens using heat may be a separate step conducting during or following the process of manufacturing and packaging a contact lens. For example, the adherent thin film may be applied during the manufacture of the lens, during heat sterilization of the lens, during packaging of the lens, or during another appropriate step of the manufacturing process. According to one embodiment of the invention, the contact lens is heated to a temperature of about 120°C to about 150⁰C, more preferably about 120⁰C to about 130°C, most preferably about 12O⁰C to about 125⁰C. For certain compositions, in particular silicone compositions, to minimize the possibility of oxidation of the composition or the formation of formeldahyde, the temperature of the heating process should not exceed 150 degrees Celsius. Heat sterilization of contact lenses is typically carried out at a temperature range of 121 to 124 degrees Celsius, with standard pressures and times.

[0142] According to another embodiment of the invention, the thin film composition is applied to the contact lens surface, for example, by the eye doctor, eye technician or the contact lens wearer. Several methods of application of the thin film to the contact lens have been developed. According to one embodiment, a drop of the thin film composition is placed on one or both surfaces of the contact lens. Then the lens is rubbed between the fingers for a few seconds up to 10 seconds. Then the lens is irrigated with a saline solution or a contact lens wetting solution, rubbed briefly again between the fingers, irrigated again and then inserted in the eye. According to another embodiment, a drop of the thin film composition is placed on one or both surfaces of the contact lens. Then the lens is rubbed briefly to spread the composition on the lens. Then the lens is placed in a saline solution or contact lens wetting solution for about 3 to 5 minutes in a contact lens container. Then the container is shaken vigorously for 5 seconds up to 15 seconds. Then the lens is removed from the container and inserted in the eye. According to another embodiment, a drop of the thin film composition is placed on one or both surfaces of the contact lens. Then the lens is rubbed briefly to spread the composition on the lens. Then the lens is placed in a saline solution or contact lens wetting solution for at least 10 minutes up to overnight in a contact lens container. Then the lens is removed from the container, irrigated with saline solution or contact lens wetting solution and inserted in the eye.

Packaging and Storage

[0143] According to one embodiment, the composition is provided to the user in a package from which the user can dispense the composition. For example, according to various embodiments the composition is packaged in a bottle, optionally containing a dropper or application tip, a unit-dose sterile sealed dropper, or another container used or contemplated by those in the field.

[0144] According to one embodiment, the improvement in near vision is dependent on the percentage of the composition consisting of the volatile cyclomethicone. Therefore, it is very important to maintain stability of this composition during manufacture, sterilization, packaging, dispensing and use so that the cyclomethicone does not volatilize away before the contact lens is treated for use. Containers made of glass, polypropylene, epoxy coated aluminum tubes and other suitable materials which can serve as an effective barrier against the volatilizing of the cyclomethicone are important for product stability. Also, manufacturing, sterilization and packaging processes which maintain the desired percentage of cyclomethicone in the composition will also be important for product effectiveness.

[0145] According to this embodiment, the combination is particularly sensitive to cyclomethicone' s volatility as a solvent. Exemplary containers include a glass container, a polypropylene container, or an aluminium container with an epoxy lining. These exemplary containers may prevent cyclomethicone vaporization and minimize the loss of a desired percentage of cyclomethicone in the mixture over a necessary period of time.

Commercial applicability

[0146] The thin film mixtures of this invention have been used to coat contact lenses and store them for several weeks with retention of the improved visual performance. Daily wear soft lenses, which now constitute about 10% of the soft contact lens market, may be coated with adherent thin films of the present invention, either at the time of manufacture or prior to use, to improve their comfort and visual performance. Lenses tested include Focus dailies, Accuvue dailies, Accuvue II, and Frequency 55 torics.

[0147] The present invention may also be used to coat lenses on a daily basis to extend the life of extended wear (with removal daily just for insertion of the present invention) or daily wear contact lenses, which are reworn for a period of time, and thereby lengthen the time duration before the quality of the contact lens surface becomes degraded. According to this embodiment, the composition is applied to a surface of the contact lens on a periodic basis, for example, hourly, daily, or as needed, according to one of the methods of application contemplated above. Additionally, the contact lens treated according to this method can be manufactured to include an initial adherent thin film layer of the composition, supplemented with subsequent administrations of the composition according to the needs of the user.

[0148] The present invention may also be used to coat these lenses daily for the purpose of improving comfort. The present invention may also be used to coat these lenses daily for the purpose of improving visual performance, including distance and near acuity, depth of focus, and quality of vision.

[0149] Although there has been hereinabove described a particular composition for the purpose of illustrating the manner in which the invention may be used to advantage, it should be appreciated that the invention is not limited thereto. Accordingly, any and all modifications, variations or equivalent arrangements, which may occur to those skilled in the art, should be considered to be within the scope of the present invention as defined in the appended claims.

Claims

CLAIMSWhat is claimed is:

1. A method of improving a patient's vision comprising:

a) providing a composition comprising at least one polymer selected from the group consisting of silicones, fluorinated silicones, perfluorocarbons, fluorinated alcohols, and fluorinated polyethers; and

b) applying the composition to at least one surface of a contact lens for insertion into the patient's eye.

2. The method of claim 1 wherein the polymer comprises about 80% to about 95% of the composition.

3. The method of claim 1 wherein the polymer comprises about 85% to about 90% of the composition.

4. The method of claim 1 wherein the polymer comprises dimethicone.

5. The method of claim 4 wherein the dimethicone comprises a viscosity of about 10 to about 20,000 centistokes.

6. The method of claim 4 wherein the dimethicone comprises a viscosity of about 250 to about 15,000 centistokes.

7. The method of claim 4 wherein the dimethicone comprises a viscosity of about 12,500 centistokes.

8. The method of claim 1 wherein the polymer comprises a fluoroguerbet.

9. The method of claim 8 wherein the fluoroguerbet comprises a 38 carbon guerbet.

10. The method of claim 1 wherein the polymer comprises a fluorine concentration of about 1 to about 10%.

11. The method of claim 1 wherein the polymer comprises a fluorine concentration of about 3 to about 5%

12. The method of claim 1 wherein the composition further comprises a solvent.

13. The method of claim 12 wherein the solvent comprises about 5% to about 25% of the composition.

14. The method of claim 12 wherein the solvent comprises about 7.5% to about 15% of the composition.

15. The method of claim 12 wherein the solvent is selected from the group consisting of silicones, fluorinated silicones, perfluorocarbons, fluorinated alcohols, and fluorinated polyethers.

16. The method of claim 12 wherein the solvent comprises cyclomethicone.

17. The method of claim 16 wherein the cyclomethicone comprises a viscosity of about 0.5 to about 5 centistokes.

18. The method of claim 16 wherein the cyclomethicone comprises a viscosity of about 1 to about 4 centistokes.

19. The method of claim 1 or claim 12 wherein improved vision comprises improved depth of focus.

20. The method of claim 1 or claim 12 wherein improved vision comprises improved near acuity.

21. The method of claim 1 or claim 12 wherein improved vision comprises improved distance acuity.

22. The method of claim 1 or claim 12 wherein improved vision comprises improved visual quality.

23. The method of claim 1 or claim 12 wherein improved vision comprises reduced spherical aberration.

24. The method of claim 1 or claim 12 wherein improved vision comprises an improved Strehl ratio and improved optical resolution closer to the diffraction limit.

25. The method of claim 1 or claim 12 wherein improved vision comprises improved contrast sensitivity.

26. The method of claim 1 or claim 12 wherein improved vision comprises improved night vision.

27. The method of claim 1 or claim 12 further comprising the step of applying the composition to at least one surface of the contact lens during manufacturing or packaging of the contact lens.

28. The method of claim 26 further comprising the step of heat sterilizing the contact lens prior to application of the composition to at least one surface of the contact lens.

29. The method of claim 26 further comprising the step of heating the contact lens following application of the composition to at least one surface of the contact lens.

30. The method of claim 28 further comprising the step of heating the contact lens to a temperature of about 120 to 150 degrees Celsius.

31. The method of claim 1 or claim 12 further comprising the step of packaging the contact lens with the composition.

32. The method of claim 1 or claim 12 further comprising the step of packaging the compsition in a container comprising glass, polypropylene, or epoxy- lined aluminum.

33. The method of claim 1 or claim 12 wherein the composition remains on the contact lens following insertion into the patient's eye for at least two hours.

34. The method of claim 1 or claim 12 wherein the composition remains on the contact lens following insertion into the patient's eye for at least four hours.

35. The method of claim 1 or claim 12 wherein the composition remains on the contact lens following insertion into the patient's eye for at least twelve hours.

36. The method of claim 1 or claim 12 wherein the contact lens comprises a daily disposable lens.

37. The method of claim 1 or claim 12 wherein the contact lens comprises a continuous use contact lens.

38. The method of claim 1 or claim 12 wherein the contact lens comprises a daily wear lens.

39. The method of claim 1 or claim 12 wherein the contact lens comprises a planned replacement lens.

40. A method of improving a patient's vision comprising:

a) providing a composition comprising at least one polymer selected from the group consisting of silicones, fluorinated silicones, perfluorocarbons, fluorinated alcohols, and fluorinated polyethers;

b) applying the composition to at least one surface of a contact lens for insertion into the patient's eye; and

c) index matching the composition to the contact lens material;

wherein the composition further reduces front and back light scatter.

41. The method of claim 39 where the index or refraction of the composition comprises between 1.2 and 1.48.

42. The method of claim 39 where the index of refractionof the composition comprises between 1.30 and 1.45.

43. The method of claim 39 wherein the index of refraction of the composition comprises between 1.38 and 1.40.

44. A composition for application to at least one surface of a contact lens for improving a patient's vision comprising at least one polymer selected from the group consisting of silicones, fluorinated silicones, perfluorocarbons, fluorinated alcohols, and fluorinated polyethers.

45. The composition of claim 44 wherein the polymer comprises about 75% to about 95% of the composition.

46. The composition of claim 44 wherein the polymer comprises about 85% to about 90% of the composition.

47. The composition of claim 44 wherein the polymer comprises dimethicone.

48. The composition of claim 47 wherein the dimethicone comprises a viscosity of about 10 to about 20,000 centistokes.

49. The composition of claim 47 wherein the dimethicone comprises a viscosity of about 250 to about 15,000 centistokes.

50. The composition of claim 47 wherein the dimethicone comprises a viscosity of about 12,500 centistokes.

51. The composition of claim 44 wherein the polymer comprises a fluoroguerbet.

52. The composition of claim 51 wherein the fluoroguerbet comprises a 38 carbon guerbet.

53. The composition of claim 44 wherein the polymer comprises a fluorine concentration of about 1 to about 10%.

54. The composition of claim 44 wherein the polymer comprises a fluorine concentration of about 3 to about 5%

55. The composition of claim 44 wherein the composition further comprises a solvent.

56. The composition of claim 55 wherein the solvent comprises about 5% to about 25% of the composition.

57. The composition of claim 55 wherein the solvent comprises about 7.5% to about 15% of the composition.

58. The composition of claim 55 wherein the solvent is selected from the group consisting of silicones, fluorinated silicones, perfluorocarbons, fluorinated alcohols, and fluorinated polyethers.

59. The composition of claim 55 wherein the solvent comprises cyclomethicone.

60. The composition of claim 59 wherein the polymer comprises dimethicone and the solvent comprises cyclomethicone and wherein the polymer comprises about 75% to 93.5% of the composition and the solvent comprises about 25% to 7.5% of the composition.

61. The composition of claim 59 wherein the cyclomethicone comprises a viscosity of about 0.5 to about 5 centistokes.

2. The composition of claim 59 wherein the cyclomethicone comprises a viscosity of about 1 to about 4 centistokes.