RESUMO
PURPOSE: To assess changes in lid papillae and symptoms after use of a hydrogen peroxide-containing solution (H2O2) for 3 months by symptomatic contact lens wearers. METHODS: This randomized, controlled, investigator-masked, parallel group study enrolled symptomatic lens wearers with at least mild lid papillae who habitually used a biguanide-preserved multipurpose solution (BMPS). Subjects were randomized to habitual BMPS or H2O2 for 3 months to care for their lenses. Lid papillae severity (0-4) was graded in four zones of each eye at baseline and at 30, 60, and 90 days. Subjects rated frequency and intensity of symptoms and completed the Contact Lens Dry Eye Questionnaire (CLDEQ-8) at the same time points. Lens cases used for 1 month were collected from subjects in the H2O2 group, and residual peroxide concentration was analyzed at disinfection time. RESULTS: In all, 131 subjects were randomized to H2O2 (n = 64) or BMPS (n = 67) and underwent post-baseline assessment. The H2O2 group showed significantly greater improvements in lid papillae from baseline to day 90 than the BMPS group (H2O2, least square mean [LSM] difference [baseline-day 90] in maximum score 0.904 [95% CI 0.744-1.064]; BMPS, LSM difference 0.423 [95% CI 0.271-0.576]; p < 0.001). Frequency and intensity of symptoms, including grittiness, end-of-day dryness, irritation, burning/stinging, itchiness, and blurry vision, were significantly lower for H2O2 than for BMPS at days 30, 60, and 90 (all p ≤ 0.045), as were mean CLDEQ-8 scores (3-mo scores 10.6 ± 6.30 vs.15.0 ± 7.29, p < 0.001). Residual peroxide concentration in 61 used lens cases ranged from 6 to 55 ppm (mean, 15 ± 8 ppm) and 95% of cases had residual peroxide less than 30 ppm. CONCLUSIONS: Symptomatic contact lens wearers using the H2O2 solution showed greater reductions in lid papillae and symptoms at 90 days than did subjects using BMPS. Cases used for 1 month neutralized peroxide at disinfection time to levels below those detectable by ocular tissues.
