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M.F. Mowrey-McKee, A. Sills, C. Amos, S. Lambert, M. Ajello, M. George, K. Lindley; Preclinical and Clinical Data: New, Improved Contact Lens Care Disinfecting Solution - SOLO-Care PLUS . Invest. Ophthalmol. Vis. Sci. 2003;44(13):3693.
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Purpose: To evaluate the cytotoxicity, antimicrobial activity, and clinical performance of SOLO-care PLUS, a new contact lens care disinfecting solution. Methods: Cytotoxicity was evaluated according to the USP Direct Contact Test and according to modifications of the USP Elution Test. Contact lenses cycled in SOLO-care PLUS were evaluated on monolayers of L929, mouse fibroblast cells, for cell death. For the elution test L929 cell monolayers were exposed to SOLO-care PLUS diluted 1:3 with media and evaluated by either counting the cells (Coulter counter) or by microscopic examination using trypan blue. The antimicrobial activity was evaluated according to the Stand Alone Test in ISO 14729 and according to the Regimen Test in ISO 14729 with organic soil (FDA version). The clinical performance was evaluated in a three month randomized contralateral trial initiated with 95 patients using SOLO-care PLUS for one lens and SOLOcare for the contralateral lens. Results: SOLO-care PLUS exhibited a noncytotoxic response in the modified USP Elution Test with cell monolayers similar to the saline negative control. Lenses cycled in SOLO-care PLUS were noncytotoxic. SOLO-care PLUS passed the primary criteria for the ISO Stand Alone Test with the following log reductions: 3.4 for Fusarium solani, 1.2 for Candida albicans, 4.6 for Staphylococcus aureus, 4.9 for Pseudomonas aeruginosa, and 5.0 for Serratia marcescens. The ISO Regimen Test was passed with a NO RUB regimen using organic soil. Overall comfort was consistently higher with SOLO-care PLUS compared to SOLOcare. SOLO-care PLUS received a statistically significantly higher comfort preference rating at one and three months. Conclusions: New and improved SOLO-care PLUS has been shown to provide increased patient comfort and enhanced antimicrobial activity compared to SOLO-care.
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