Clinical Cure of Bacterial Conjunctiviti with Azithromycin 1%: Vehicle-Controlled, Double-Maked Clinical Trial Original Reearch Article

Purpoe To analyze the effect of azithromycin 1% ophthalmic olution in Duraite (Inite Viion, Inc, Alameda, California, UA) on bacterial conjunctiviti. Deign Propective, randomized, vehicle-controlled, parallel-group, double-maked multicenter clinical tudy. Method Eligible male or female participant with a clinical diagnoi of acute bacterial conjunctiviti were randomized to either 1% azithromycin in Duraite or vehicle for five day. Infected eye were doed twice daily on day 1 and 2 and once daily on day 3 through 5. Conjunctival culture were obtained at baeline, viit 2 (day 3 or 4), and viit 3 (day 6 or 7). The primary end point wa clinical reolution of ign and ymptom (rating of zero on ocular dicharge, bulbar and palpebral injection) at viit 3. Efficacy meaure were clinical reolution and bacterial eradication a evaluated in the per-protocol population. afety wa aeed by advere event, lit-lamp finding, and ophthalmocopy. Reult Two hundred and eventy-nine participant (n = 130, 1% azithromycin in Duraite; n = 149, vehicle), age one to 96 year, were evaluated for efficacy. Clinical reolution with azithromycin ophthalmic olution wa tatitically ignificant compared with that of vehicle (P = .030) at viit 3. Bacterial eradication rate with azithromycin ophthalmic olution reached 88.5% at viit 3 (P < .001) and included ome pathogen reitant to azithromycin in vitro. Overall, advere event rate were imilar in both treatment group. Concluion Azithromycin 1% ophthalmic olution in Duraite howed tatitically ignificant difference in clinical reolution and bacterial eradication rate when compared with vehicle. Becaue it wa well tolerated in thi population, it may be a viable treatment option for children and adult with bacterial conjunctiviti.