Clinical evaluation of a new multi-purpose disinfecting solution in symptomatic contact lens wearers

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.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.) or Regimen 2 (ReNu MultiPlus MPS No Rub Formula, Bausch and Lomb Inc.). At Day 0 (baseline), Days 14 and 28 subjects recorded comfort and ocular symptoms, wearing time, rewetting drop and lens removal frequency, and investigators assessed slit-lamp findings, lens deposits and wettability, and visual acuity.Total corneal staining mean score was significantly lower for the Regimen 1 group at Day 14 (P