Protection of Contact Lenses from Microbial Contamination Caused by Handling

Abstract

A sealed contact lens package contains a sterile, unworn contact lens and a contact lens packaging solution comprising epsilon polylysine (εPLL). The εPLL protects the contact lens from microbial contamination caused by handling the lens when it is removed from its package.

What is claimed is: 
     
         1 . A sealed contact lens package comprising a sterile, unworn contact lens and a contact lens packaging solution comprising epsilon polylysine (εPLL), wherein the unworn contact lens exhibits reduced contamination from at least one microbe, wherein said reduced contamination is determined by a test where  Pseudomonas aeruginosa  (PA) introduced to the lens during removal from the contact lens packaging solution compared to a control contact lens packaged in an identical contact lens packaging solution but without said εPLL, and wherein the unworn contact less results in less than a two log kill of PA compared to the control contact lens when tested after 24 hours incubation with 10 4  CFU PA using an in vitro bioactivity assay. 
     
     
         2 . The package of  claim 1 , wherein the contact lens is a silicone hydrogel contact lens. 
     
     
         3 . The package of  claim 1 , wherein the contact lens is a non-ionic contact lens. 
     
     
         4 . The package of  claim 1 , wherein the contact lens is a daily disposable contact lens. 
     
     
         5 . The package of  claim 1 , wherein the sealed contact lens package comprises a plastic base member that comprises a cavity and a flange region extending outwardly around the cavity, and a removable foil attached to the flange region. 
     
     
         6 . The package of  claim 1 , wherein the packaging solution comprises between 5 ppm and 500 ppm εPLL. 
     
     
         7 . A sealed contact lens package comprising:
 a) a plastic base member comprising a cavity which retains a sterile, unworn contact lens and a contact lens packaging solution comprising epsilon polylysine (εPLL); and   b) a resealable cover that forms a liquid-tight seal with the plastic base member, wherein the unworn contact lens exhibits reduced contamination from at least one microbe, wherein said reduced contamination is determined by a test where  Pseudomonas aeruginosa  (PA) introduced to the lens during removal from the contact lens packaging solution compared to a control contact lens packaged in an identical contact lens packaging solution but without said εPLL.   
     
     
         8 . The package of  claim 7 , wherein the contact lens is a silicone hydrogel contact lens. 
     
     
         9 . The package of  claim 7 , wherein the contact lens is an ionic contact lens. 
     
     
         10 . The package of  claim 7 , wherein the contact lens is a daily wear contact lens. 
     
     
         11 . The package of  claim 7 , wherein the plastic base member comprises a plurality of threads for engagement with a compatible set of threads on the resealable cover. 
     
     
         12 . The package of  claim 7 , wherein the packaging solution comprises between 5 ppm and 500 ppm εPLL. 
     
     
         13 . The package of  claim 1 , wherein the at least one microbe is  Pseudomonas aeruginosa.    
     
     
         14 . The package of  claim 1 , wherein the at least one microbe is  Staphylococcus aureus.    
     
     
         15 . The package of  claim 1 , wherein the at least one microbe is a microbe found in microbial keratitis. 
     
     
         16 . A method of manufacturing the sealed contact lens package, said method comprising: placing an unworn contact lens and a contact lens packaging solution comprising εPLL in a receptacle configured to receive a contact lens and sealing the receptacle with a cover to provide a sealed contact lens package, wherein the unworn contact lens exhibits reduced contamination from at least one microbe, wherein said reduced contamination is determined by a test where  Pseudomonas aeruginosa  (PA) introduced to the lens during removal from the contact lens packaging solution compared to a control contact lens packaged in an identical contact lens packaging solution but without said εPLL, and wherein the unworn contact less results in less than a two log kill of PA compared to the control contact lens when tested after 24 hours incubation with 10 4  CFU PA using an in vitro bioactivity assay and/or wherein the contact lens package comprises a resealable cover. 
     
     
         17 . The method of  claim 16 , further comprising sterilizing the unworn contact lens by autoclaving the sealed contact lens package.