Biocompatibility Evaluation of Contact Lens Multipurpose Solutions Through Novel Genotoxicity Assays

Abstract

Abstract

Introduction:

Genotoxicity testing is necessary to address potential mutagenic characteristics of pharmaceutical candidates and medical devices depending on their intended use. Adapting such tests to contact lens multipurpose solutions (MPS) may be required due to their antimicrobial nature or to fulfill specific regulatory requirements. We describe a novel methodology for genotoxicity and biocompatibility evaluation of MPS in the context of traditional testing.

Materials and Methods:

Blink RevitaLens^® Multipurpose Disinfecting Solution (MPDS) or contact lens (Acuvue^® Advance and Acuvue^® 2 brand) extracts were tested by Ames assay and Chromosome Aberration (ChrAb) Assays. A novel procedure for cycling contact lenses in MPDS was developed for testing. Before assays with the Blink RevitaLens MPDS disinfectant ingredient, Alexidine Dihydrochloride (ALX) was diluted for dose-range tests identifying TA100 or Chinese Hamster Ovary cytotoxicity levels to determine the amount of ALX appropriate for each assay.

Results:

MiniScreen Ames and Ames show Blink RevitaLens MPDS and the contact lens extracts did not increase the number of revertant colonies compared to saline, suggesting nonmutagenicity. The test articles also did not increase ChrAb, indicating they are nonclastogeneic. Below its cytotoxic limits, ALX did not increase the frequency of revertants in the Ames assay or demonstrate chromosome changes compared with controls.

Discussion/Conclusions:

Results from novel and standard genotoxicity assays demonstrated that Blink RevitaLens MPDS and ALX are not genotoxic or clastogenic. Novel cycling of contact lenses in MPDS is beneficial and accurate for biocompatibility testing on MPDS.