Purpose: To evaluate the safety and efficacy of a new multi-purpose disinfecting solution (MPDS) in symptomatic soft contact lens wearers using Group IV soft lenses and compare its performance with that of a marketed MPS.
Methods: This was a 4-week, randomized, concurrently controlled, double-masked, multi-site study involving 362 subjects at 19 investigational sites in the US. Existing Group IV lens wearers, pre-screened to be symptomatic for contact lens-related ocular discomfort, were fitted with a new pair of lenses that matched their pre-study lens brand then randomly assigned to one of two treatment regimens: Regimen 1 (OPTI-FREE RepleniSH MPDS, Alcon Laboratories Inc.
This was a multi-site, 231-subject double-masked, bilateral crossover study to evaluate subjective comfort and satisfaction, corneal staining and lens deposits with two 'no rub' multi-purpose solutions (MPS) used with FDA Group II (alphafilcon A, SofLens 66, Bausch & Lomb) and Group IV (etafilcon A, SUREVUE, Johnson & Johnson Vision Care) soft contact lenses. Subjects used each of the two MPS, Regimen 1 (OPTI-FREE EXPRESS Multi-Purpose Disinfecting Solution No Rub Lasting Comfort Formula, Alcon Laboratories) and Regimen 2 (ReNu MultiPlus Multi-Purpose Solution, Bausch & Lomb), for 28 days. They wore the same lens type for the duration of the study and were evaluated on days 0, 14 and 28 of each treatment period.
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