Packaging Solutions

Abstract

The present invention is directed to new and improved packaging systems for storing ophthalmic devices such as contact lenses and to methods for packaging such ophthalmic devices with solutions to improve the comfort of the lenses during wear. In particular, the present invention is directed to a packaging system for storing an ophthalmic device in an aqueous packaging solution comprising hyaluronic acid or a salt thereof. Such solutions are retained on the surface of an unused lens for extended periods of time, resulting in surface modification that persists in the eye, which may provide significant improvement in the wetting properties of fresh contact lenses used for the first time and, moreover, even several hours after lens insertion, thereby preventing dryness and improving lubricity.

1 . A method of preparing a package comprising a storable, sterile ophthalmic device, the method comprising:
 (a) immersing an ophthalmic device in an aqueous packaging solution comprising hyaluronic acid or salt thereof, wherein the aqueous packaging solution has an osmolality of at least about 200 mOsm/kg and a pH in the range of about 4 to about 9;   (b) packaging the solution and the device in a manner preventing contamination of the lens by microorganisms; and   (c) sterilizing the packaged solution and device.   
     
     
         2 . The method of  claim 1 , wherein the ophthalmic device is a contact lens. 
     
     
         3 . The method of  claim 1 , wherein the ophthalmic device is a silicone hydrogel contact lens. 
     
     
         4 . The method of  claim 1 , wherein the hyaluronic acid or salt thereof has a number average molecular weight of about 10,000 to about 10,000,000. 
     
     
         5 . The method of  claim 1 , wherein the hyaluronic acid or salt thereof has a number average molecular weight of about 50,000 to about 2,000,000. 
     
     
         6 . The method of  claim 1 , wherein the hyaluronic acid or salt thereof has a number average molecular weight of about 100,000 to about 1,000,000. 
     
     
         7 . The method of  claim 1 , wherein the concentration of the hyaluronic acid or salt thereof in the aqueous packaging solution is about 0.001 to about 1% w/w. 
     
     
         8 . The method of  claim 1 , wherein the concentration of the hyaluronic acid or salt thereof in the aqueous packaging solution is about 0.05 to about 0.5% w/w. 
     
     
         9 . The method of  claim 1 , wherein the concentration of the hyaluronic acid or salt thereof in the aqueous packaging solution is about 0.1 to about 0.3% w/w. 
     
     
         10 . The method of  claim 1 , wherein the aqueous packaging solution further comprises a buffering agent. 
     
     
         11 . The method of  claim 1 , further comprising hermetically sealing the ophthalmic device and the aqueous packaging solution in the package. 
     
     
         12 . The method of  claim 11 , wherein heat sterilization is performed subsequent to sealing of the package. 
     
     
         13 . The method of  claim 1 , wherein the aqueous packaging solution does not contain an effective disinfecting amount of a disinfecting agent. 
     
     
         14 . The method of  claim 1 , wherein the aqueous packaging solution does not contain a germicide compound. 
     
     
         15 . The method of  claim 1 , wherein the aqueous packaging solution does not contain a surfactant. 
     
     
         16 . The method of  claim 13 , wherein the aqueous packaging solution further does not contain a surfactant. 
     
     
         17 . A packaging system for the storage of an ophthalmic device comprising a sealed container containing one or more unused ophthalmic device immersed in an aqueous packaging solution comprising hyaluronic acid or a salt thereof, wherein the solution has an osmolality of at least about 200 mOsm/kg, a pH of about 4 to about 9 and is heat sterilized. 
     
     
         18 . The packaging system of  claim 17 , wherein the ophthalmic device is a contact lens. 
     
     
         19 . The packaging system of  claim 17 , wherein the ophthalmic device is a silicone hydrogel contact lens. 
     
     
         20 . The packaging system of  claim 17 , wherein the hyaluronic acid or salt thereof has a number average molecular weight of about 10,000 to about 10,000,000. 
     
     
         21 . The packaging system of  claim 17 , wherein the hyaluronic acid or salt thereof has a number average molecular weight of about 50,000 to about 2,000,000. 
     
     
         22 . The packaging system of  claim 17 , wherein the hyaluronic acid or salt thereof has a number average molecular weight of about 100,000 to about 1,000,000. 
     
     
         23 . The packaging system of  claim 17 , wherein the concentration of the hyaluronic acid or salt thereof in the aqueous packaging solution is about 0.001 to about 1% w/w. 
     
     
         24 . The packaging system of  claim 17 , wherein the concentration of the hyaluronic acid or salt thereof in the aqueous packaging solution is about 0.05 to about 0.5% w/w. 
     
     
         25 . The packaging system of  claim 17 , wherein the concentration of the hyaluronic acid or salt thereof in the aqueous packaging solution is about 0.1 to about 0.3% w/w. 
     
     
         26 . The packaging system of  claim 17 , wherein the aqueous packaging solution further comprises a buffering agent. 
     
     
         27 . The packaging system of  claim 17 , wherein the package is heat sterilized subsequent to sealing of the package. 
     
     
         28 . The packaging system of  claim 17 , wherein the aqueous packaging solution does not contain an effective disinfecting amount of a disinfecting agent. 
     
     
         29 . The packaging system of  claim 17 , wherein the aqueous packaging solution does not contain a germicide compound. 
     
     
         30 . The packaging system of  claim 17 , wherein the aqueous packaging solution does not contain a surfactant. 
     
     
         31 . The packaging system of  claim 28 , wherein the aqueous packaging solution further does not contain a surfactant. 
     
     
         32 . A method of treating an ophthalmic lens, the method comprising storing the lens in an aqueous packaging solution comprising hyaluronic acid or a salt thereof, wherein the aqueous packaging solution does not contain an effective disinfecting amount of a disinfecting agent.