Ophthalmic Compositions with an Amphoteric Surfactant, Hyaluronic Acid and Polyquaternium-1

Abstract

Ophthalmic compositions that comprise 0.5 ppm to 15 ppm α-[4-tris(2-hydroxyethyl)-ammonium chloride-2-butenyl]poly[1-dimethyl ammonium chloride-2-butenyl]-Ω-tris(2-hydroxyethyl) ammonium chloride; 0.005 wt. % to 0.05 wt. % hyaluronic acid; citrate, citric acid or a mixture thereof; and 0.01 wt. % to 0.8 wt. % of an amphoteric surfactant of general formula Iwherein R1 is R or —(CH2)n-NHC(O)R, wherein R is a C8-C30alkyl optionally substituted with hydroxyl and n is 2, 3 or 4; R2 and R3 are each independently selected from the group consisting of hydrogen and C1-C4alkyl; R4 is a C2-C8alkylene optionally substituted with hydroxyl; and Y is CO2− or SO3−. The invention is also direct to the use of the ophthalmic compositions to clean and disinfect contact lenses, and in particular, soft, silicone hydrogel contact lenses.

Description

[0001]This application claims the benefit of U.S. patent application Ser. No. 12 / 023,509 filed Jan. 31, 2008 under 35 U.S.C. § 120.[0002]The present invention relates to ophthalmic compositions with an amphoteric surfactant, hyaluronic acid and polyquatemium-1. The invention is also directed to the use of the ophthalmic compositions to clean and disinfect contact lenses.BACKGROUND OF THE INVENTION[0003]During normal use, contact lenses become soiled or contaminated with a wide variety of compounds that can degrade lens performance. For example, a contact lens will become soiled with biological materials such as proteins or lipids that are present in the tear fluid and which adhere to the lens surface. Also, by handling of the contact lens, sebum (skin oil) or cosmetics or other materials can soil the contact lens. These biological and external contaminants can affect visual acuity and patient comfort. Accordingly, it is important to remove any debris from the lens surface for contin...

AI Technical Summary

Benefits of technology

The solution exhibits exceptional biocidal activity and stability with minimal impact on the ocular surface, meeting or exceeding the superficial punctate corneal staining profiles of leading market solutions and passing stringent testing protocols, ensuring safe and effective lens care.

Problems solved by technology

During normal use, contact lenses become soiled or contaminated with a wide variety of compounds that can degrade lens performance.

These biological and external contaminants can affect visual acuity and patient comfort.

However, as with any antimicrobial component there remains a tradeoff between the concentration of the antimicrobial component in the solution and the comfort experienced by the patient.

Although the precise mechanisms that control the depth and extent of the fluorescence signal associated with superficial punctate corneal staining remains unclear, the studies as a whole do provide scientific support that such staining does not reflect corneal injury or toxicity.

In fact, both epidemiological and experimental evidence demonstrates a lack of correlation between superficial punctate corneal staining and the institution of conical infections.

Again, these reports offer no scientific or clinical data to support such assertions.

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