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.) 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.
Results: Total corneal staining mean score was significantly lower for the Regimen 1 group at Day 14 (P<or=0.02). Comfort and dryness mean scores were significantly better for Regimen 1 compared to Regimen 2 at Day 28 (P<or=0.02; P<or=0.007) and mean scores for scratchiness and burning were significantly lower at Day 14 (P<or=0.04; P<or=0.01). Significant differences were noted in favor of Regimen 1 on 12 of the 12 Likert questionnaire statements (P<0.05). Average lens wearing time was significantly greater for the Regimen 1 group compared to the Regimen 2 group at Day 14 (P<0.05). Lens deposits were significantly lower with Regimen 1 than with Regimen 2 (P<or=0.02).
Conclusion: This study shows that the new formulation is safe and efficacious when used by symptomatic Group IV lens wearers. Comfort, ocular signs and symptoms and wearing times in patients experiencing problems with their contact lenses can be influenced by the choice of MPS. Selecting an appropriate lens care product enhances patients' wearing experience, maintains optimal lens performance and may help to prevent drop-out.