Prospective, Randomized Clinical Trial of Povidone-lodine 1.25% Solution Versus Topical Antibiotics for Treatment of Bacterial Keratitis

PURPOSE: To compare povidone-iodine 1.25% ophthalmic solution with topical antibiotics for treatment of bacterial keratitis in areas of the world where use of effective topical antibiotics may not be an option. STUDY DESIGN: Randomized, controlled, investigator masked clinical trial. METHODS: We randomized 172 individuals with bacterial keratitis to topical treatment with povidone-iodine or antibiotics (neomycin polymyxin B gramicidin in the Philippines; ciprofloxacin 0.3% in India). Using survival analysis, we compared intervals from start of treatment to "presumed cure" (primary outcome measure, defined as a closed epithelial defect without associated inflammatory signs) and to "recovering" (residual epithelial defect < 1 mm(2) with only minimal inflammation). RESULTS: Median interval to presumed cure in the Philippines was 7 days for povidone-iodine and 7 days for neomycin polymyxin B gramicidin (95% confidence interval [CI] for difference in median interval, 9.5 to 0.7 days) and in India was 12 days for povidone-iodine and 17 days for ciprofloxacin (95% CI, 35.2 to 3.2 days). Hazard ratio (HR) for presumed cure among those treated with povidone-iodine (vs antibiotics) was 1.46 in the Philippines (95% CI, 0.90-2.36; P =.13) and 1.70 in India (95% CI, 0.73-3.94; P =.22). Comparisons of intervals to recovering and HR for recovering also revealed no significant differences between treatment groups in either country. CONCLUSIONS: There is no significant difference between the effect of topical povidone-iodine 1.25% and topical antibiotics commonly available in the developing world for treatment of bacterial keratitis. Povidone-iodine 1.25%, which is widely available and inexpensive, can be considered for treatment of bacterial keratitis when antibiotic treatment is not practical. (Published by Elsevier Inc.)