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E. Kao, L. C. Huang, N. Tarantino; Corneal Staining Profiles of Two Contact Lens Multi-Purpose Solutions With Balafilcon A Contact Lenses. Invest. Ophthalmol. Vis. Sci. 2010;51(13):1519.
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Corneal staining induced by contact lens (CL) and multi-purpose solution (MPS) combinations has previously been reported as an indicator of ocular surface cytotoxicity. This study aims to investigate the clinical performance of two CL-MPS combinations by the determination of their corneal staining profiles, defined as corneal staining levels measured as a function of lens wear duration.
An investigational MPS and Opti-Free RepleniSH MPS (Alcon) were evaluated with balafilcon A (PureVision, Bausch & Lomb) silicone hydrogel CLs in a doubled-masked, paired-eye comparison at specific lens wear-times. Thirty subjects were randomized to wear one lens soaked in the investigational MPS in one eye and another lens soaked in Opti-Free RepleniSH MPS in the contralateral eye. Baseline evaluations were conducted after a minimum 12-hour washout period just prior to lens wear on each day of the study. Follow-up visits occurred after 1, 2, 4 and 6 or more hours (end-of-day) of lens wear. Corneal staining severity and extent (assessed on a five-point scale), subjective comfort and visual acuity were assessed at each study visit.
No significant differences in corneal staining severity were observed between the mean scores of either CL-MPS combination at any post-insertion time point. The incidence and degree of change from baseline in corneal staining extent were generally observed to be greater in subjects wearing Opti-Free RepleniSH MPS-treated lenses. Subjects wearing Opti-Free RepleniSH MPS-treated lenses demonstrated significantly greater levels of corneal staining extent at the 2-hour time point (p=0.037) and a significantly greater change from baseline corneal staining extent (p=0.046) compared to that with the investigational MPS. A significantly higher number of subjects reported a preference for the investigational MPS over Opti-Free RepleniSH MPS at the 4-hour time point (p=0.021).
Results from this study illustrated that comparison of MPS-CL combinations can be well-characterized by corneal staining profiles that present staining as a function of lens wear time. This study also demonstrated that the investigational MPS out-performed Opti-Free RepleniSH MPS in both objective (corneal staining extent) and subjective (solution preference) measures.
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