Abstract
Purpose:
To assess lid papillae and symptoms changes with use of a hydrogen peroxide lens care solution for 3 months in symptomatic contact lens wearers.
Methods:
This randomized, controlled, investigator-masked, parallel group, multi-site study enrolled symptomatic contact lenses wearers presenting with at least mild lid papillae and habitually using a biguanide-preserved multi-purpose solution (HMPS). Eligible subjects were randomized to use their habitual solution or Clear Care® (H202) for 3 months to care for their habitual lenses. Symptoms (frequency 1-5 scale and intensity 0-5 scale) including CLDEQ-8 (0-37 scale) were assessed and lid papillae was graded with fluorescein at baseline and 3 months (0-4 scale in 3 upper lid zones and 1 lower lid zone).
Results:
128 subjects completed the study at 12 U.S. sites. H202 users showed a significant improvement in lid papillae; mean (95% CI) changes from baseline to Day 90 in maximum rated lid papillae were 0.904 (0.744, 1.064) for CC and 0.423 (0.271, 0.576) for HMPS (p<0.001). Additionally, both frequency and intensity of symptoms were significantly less for H202 vs. HMPS users by Day 90 (grittiness, end of day dryness, irritation, burning/stinging, itchiness, and blurry vision; all p≤0.035). Mean CLDEQ-8 scores after 3 months were significantly lower (better) for H202 (10.6±6.30) vs. HMPS (15.0±7.29); p<.001.
Conclusions:
The peroxide lens care solution was well-tolerated by symptomatic contact lens wearers and is superior to biguanide-preserved MPSs at reducing lip papillae and contact lens wearing symptoms when used for 90 days.