Comparative antimicrobial efficacy of multi-purpose lens care solutions using the FDA's revised guidance document for industry: stand-alone primary criteria.

PURPOSE

We evaluated six single-bottle, multi-purpose lens care solutions and a two component lens care system for disinfection efficacy according to the stand-alone primary criteria within the recently published U.S. Food and Drug Administration (FDA) Guidelines.

METHODS

One-tenth mL of 1 x 10(8) colony forming units (CFU)/mL of bacterial and fungal challenge organisms was added to each test solution. Following a specified period (e.g., each manufacturer's labeled minimum disinfection time), aliquots of inoculated test solution were neutralized and plated on validated recovery media. After incubation the number of viable microorganisms were enumerated and mean log reductions determined.

RESULTS

ReNu and ReNu MultiPlus met the FDA's acceptance criteria for stand-alone disinfectants against all challenge organisms: Staphylococcus aureus, Serratia marcescens, Pseudomonas aeruginosa, Candida albicans, and Fusarium solani. Opti-Free Express failed to meet the FDA's stand-alone disinfectant acceptance criteria for S. aureus, S. marcescens and C. albicans and Opti-Free Express with Opti-Free Supraclens failed to meet the acceptance criteria for either S. aureus and C. albicans. Opti-One failed to meet the FDA's stand-alone disinfectant acceptance criteria for C. albicans and F. solani. Both Complete and Solo-Care failed to meet the FDA's acceptance criteria for C. albicans.

CONCLUSIONS

This evaluation provides a direct comparison of antimicrobial activity (based on stand-alone criteria) for commercially available multi-purpose lens care solutions at their labeled minimum disinfection times. The results of this study should be considered when selecting appropriate lens care systems for patients.