Learn about the flu shot, COVID-19 vaccine, and our masking policy »
New to MyHealth?
Manage Your Care From Anywhere.
Access your health information from any device with MyHealth. You can message your clinic, view lab results, schedule an appointment, and pay your bill.
ALREADY HAVE AN ACCESS CODE?
DON'T HAVE AN ACCESS CODE?
NEED MORE DETAILS?
MyHealth for Mobile
Get the iPhone MyHealth app »
Get the Android MyHealth app »
Abstract
PURPOSE: To evaluate the efficacy and safety 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.DESIGN: Randomized, double-masked, multicenter, phase 3 clinical trial..METHODS: Subjects 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. The primary endpoint was clinical resolution in the study eye, and the key secondary efficacy endpoint was bacterial eradication, both at day 5 visit. Adverse events (AEs) were documented at all visits.RESULTS: Overall, 753 subjects were randomized (intent-to-treat [ITT] population; PVP-I/DEX [N = 324]; PVP-I [N = 108]; placebo [N = 321]); mean (SD) age was 44.3 (22.9) years, and most were female (61.2%) and white (78.1%). In all treatment groups, mean treatment compliance was >98%. The modified ITT population for the efficacy analysis comprised 526 subjects. In the study eye at the day 5 visit, clinical resolution was achieved by 50.5% (111/220) subjects in the PVP-I/DEX group versus 42.8% (95/222) in the placebo group (P = .127), and bacterial eradication was achieved by 43.3% (94/217) and 46.8% (102/218), respectively (P = .500). Treatment-emergent AEs were experienced by 32.8% (106/323), 39.8% (43/108) and 19.0% (61/321) of subjects in the safety population treated with PVP-I/DEX, PVP-I, and placebo, respectively (most mild in severity).CONCLUSION: In this study, PVP-I/DEX did not demonstrate additional benefit in clinical efficacy compared with placebo in subjects with bacterial conjunctivitis.
View details for DOI 10.1016/j.ajo.2020.03.018
View details for PubMedID 32222367