Ophthalmic composition with hyaluronic acid and polymeric biguanide

1. A method of cleaning and disinfecting a contact lens, the method comprising soaking the contact lens in a multi-purpose lens care solution for at least two hours, the lens care solution comprising:

0.8 ppm to 2 ppm of poly(hexamethylene biguanide);

0.002 wt. % to 0.015 wt. % of hyaluronic acid, wherein the weight ratio of hyaluronic acid to poly(nexamethylene biguanide) in the composition is from 45:1 to 120:1; and

0.5 ppm to 2 ppm of α-[4-tris(2-hydroxyethyl)-ammonium chloride-2-butenyl]poly[1-dimethyl ammonium chloride-2-butenyl]-ω-tris(2-hydroxyethyl)ammonium Chloride,

wherein the lens care solution maintains disinfecting ability against each of S. aureus, P. aeruginosa, S. marcescens, C. albicans and F. solani , for a storage time period of up to and including four months at 30° C., in accordance with FDA-Premarket Notification 510(k) Guidance Document for contact lens care products.

2. The method of claim 1 further comprising inserting the cleaned and disinfected contact lens into the eye without rinsing the lens after soaking.

3. The method of claim 1 further comprising rinsing the cleaned and disinfected contact lens with the lens care solution prior to inserting the lens into the eye.

4. The method of claim 1 wherein the hyaluronic acid has a glucuronic acid content that is greater than 42% by weight.

5. The method of claim 1 further comprising 0.01 wt. % to 0.05 wt. % ethylenediaminetetraacetic acid or a corresponding salt thereof.

6. The method of claim 1 wherein the hyaluronic acid or a salt thereof is obtained via a fermentation mixture comprising Streptococcus equi.

7. The method of claim 1 further comprising a disuccinate of formula IV below or a corresponding salt thereof;

wherein R 1 is selected from hydrogen, alkyl or —C( 0 )alkyl, the alkyl having one to twelve carbons and optionally one or more oxygen atoms, A is a methylene group or an oxyalkylene group, and n is from 2 to 8.

8. The method of claim 1 wherein the lens care solution maintains disinfecting ability against each of S. aureus, P. aeruginosa, S. marcescens, C. albicans and F. solani for a storage time period of up to and including four months at 40° C.

9. The method of claim 1 wherein the poly(hexamethylene biguanide) is present from 1 ppm to 2 ppm, and the α-[4-tris(2-hydroxyethyl)-ammonium chloride-2-butenyl]poly[1-dimethyl ammonium chloride-2-butenyl]-ω-tris(2-hydroxyethyl)ammonium chloride is present from 1 ppm to 2 ppm.

10. The method of claim 1 wherein the lens care solution comprises diglycine, which is present at a concentration of 0.01 wt. % to 2.0 wt. %.

11. A method of cleaning and disinfecting a contact lens, the method comprising soaking the contact lens in a multi-purpose lens care solution for at least two hours, the lens care solution comprising:

1 ppm to 2 ppm of poly(hexamethylene biguanide);

0.002 wt. % to 0.015 wt. % of hyaluronic acid, wherein the weight ratio of hyaluronic acid to poly(hexamethylene biguanide) in the composition is from 45:1 to 120:1;

1 ppm to 2 ppm of α-[4-tris(2-hydroxyethyl)-ammonium chloride-2-butenyl]poly[1-dimethyl ammonium chloride-2-butenyl]-ω-tris(2-hydroxyethyl)ammonium chloride, and

a boron buffer component selected from the group consisting of boric acid, sodium or potassium borate, tetraborate and metaborate;

wherein the lens care solution maintains disinfecting ability against each of S. aureus, P. aeruginosa, S. marcescens, C. albicans and F. solani , for a storage time period of up to and including four months at 30° C., in accordance with FDA Premarket Notification 510(k) Guidance Document for contact lens care products.

12. The method of claim 11 wherein the lens care solution comprises diglycine, which is present at a concentration of 0.01 wt. % to 2.0 wt. %.

13. The method of claim 1 wherein the contact lens comprises a silicone hydrogel.

14. The method of claim 11 wherein the contact lens comprises a silicone hydrogel.