A prospective, randomized trial of povidone-iodine 0.6% and dexamethasone 0.1% ophthalmic suspension for acute bacterial conjunctivitis
American Journal of Ophthalmology Mar 30, 2020
Ta CN, Raizman MB, Gross RD, et al. - Researchers conducted this randomized, double-masked, multicenter, phase 3 clinical trial to test the safety and effectiveness of a topical ophthalmic suspension combination of povidone-iodine (PVP-I; 0.6%) and dexamethasone (DEX; 0.1%) for infectious and inflammatory components of bacterial conjunctivitis. Individuals [n = 753; mean (SD) age was 44.3 (22.9) years] of all ages (those <3 months had to be full-term) with a diagnosis of bacterial conjunctivitis were randomized 3:1:3 to either PVP-I/DEX, PVP-I 0.6% alone, or placebo. Treatment-emergent adverse events (most mild in severity) were experienced by 32.8% (106/323), 39.8% (43/108) and 19.0% (61/321) of individuals in the safety population treated, respectively, with PVP-I/DEX, PVP-I, and placebo. In patients with bacterial conjunctivitis, PVP-I/DEX did not show additional benefit in clinical efficacy vs placebo.
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