To compare the antimicrobial effects of CLEAR CARE, a 3% hydrogen peroxide (H2O2) solution formulated for simultaneous cleaning, daily protein removal, disinfection, and storage of soft (hydrophilic) hydrogel, silicone hydrogel, and gas-permeable contact lenses, and CLEAR CARE PLUS, consisting of the 3% H2O2 solution plus a novel wetting agent, polyoxyethylene-polyoxybutylene (EOBO-21).
Three lots each of the 2 solutions were incubated with 5 compendial microorganisms required by the Food and Drug Administration (FDA) 510(k) and International Organization for Standardization (ISO) 14729 stand-alone procedures, 4 clinical isolates of Gram-positive and Gram-negative bacteria, and trophozoites and cysts of 2 Acanthamoeba strains that are associated with microbial keratitis. Microbial loads were evaluated after disinfection and neutralization.
Both solutions exceeded the FDA/ISO stand-alone primary criteria against Gram-positive and Gram-negative compendial bacteria, yeast, and mold after only 1.5-hr disinfection/neutralization. At the recommended minimum disinfection time, bacteria were reduced by 4.4 to 5.1 logs, yeast by 4.4 to 4.9 logs, and mold by 2.9 to 3.5 logs with and without organic soil. In addition, both solutions eliminated or effectively reduced populations of clinically relevant ocular bacterial isolates (4.5–5.0 logs), Acanthamoeba trophozoites (3.4–4.2 logs), and cysts (1.5–2.1 logs).
Both solutions eliminated or reduced populations of FDA/ISO compendial bacteria and fungi as well as clinically relevant microorganisms and Acanthamoeba trophozoites and cysts. The addition of EOBO-21 to the 3% H2O2 lens care solution had no impact on antimicrobial activity.
Alcon Research, Ltd (M.M.G.), Johns Creek, GA; Alcon Research, Ltd (C.M., R.W., L.C., M.C., S.S.), Fort Worth, TX; and Novartis Pharmaceuticals Corporation (J.B.), Global Drug Development, Fort Worth, TX.
Address correspondence to Manal M. Gabriel, PhD, Alcon Research Ltd, 11460 Johns Creek Parkway, Johns Creek, GA 30097; e-mail: email@example.com
The authors have no funding or conflicts of interest to disclose.
M. M. Gabriel is an employee of Alcon Research, Ltd, Johns Creek, GA, USA. C. McAnally, R. Walters, L. Clark, M. Crary, and S. Shannon are employees of Alcon Research, Ltd, Fort Worth, TX. J. Bartell is an employee of Novartis Pharmaceuticals Corporation, Global Drug Development, Fort Worth, TX.
Parts of the study results have been presented previously at the American Academy of Optometry 93rd Annual Meeting, Denver, CO, November 12 to 15, 2014; the Association of Research in Vision and Ophthalmology Annual Meeting, Denver, CO, May 3 to 7, 2015; and the British Contact Lens Association 39th Clinical Conference, Liverpool, UK, May 29 to 31, 2015.
Accepted July 15, 2018