阿奇霉素
医学
临床试验
细菌性结膜炎
不利影响
人口
随机对照试验
临床终点
内科学
外科
抗生素
生物
微生物学
环境卫生
作者
Mark B. Abelson,Warren Heller,Aron Shapiro,Erwin Si,Peng Wei Hsu,Lyle M. Bowman
标识
DOI:10.1016/j.ajo.2008.01.019
摘要
Purpose
To analyze the effect of azithromycin 1% ophthalmic solution in DuraSite (InSite Vision, Inc, Alameda, California, USA) on bacterial conjunctivitis. Design
Prospective, randomized, vehicle-controlled, parallel-group, double-masked multicenter clinical study. Methods
Eligible male or female participants with a clinical diagnosis of acute bacterial conjunctivitis were randomized to either 1% azithromycin in DuraSite or vehicle for five days. Infected eyes were dosed twice daily on days 1 and 2 and once daily on days 3 through 5. Conjunctival cultures were obtained at baseline, visit 2 (day 3 or 4), and visit 3 (day 6 or 7). The primary end point was clinical resolution of signs and symptoms (rating of zero on ocular discharge, bulbar and palpebral injection) at visit 3. Efficacy measures were clinical resolution and bacterial eradication as evaluated in the per-protocol population. Safety was assessed by adverse events, slit-lamp findings, and ophthalmoscopy. Results
Two hundred and seventy-nine participants (n = 130, 1% azithromycin in DuraSite; n=149, vehicle), age one to 96 years, were evaluated for efficacy. Clinical resolution with azithromycin ophthalmic solution was statistically significant compared with that of vehicle (P = .030) at visit 3. Bacterial eradication rates with azithromycin ophthalmic solution reached 88.5% at visit 3 (P < .001) and included some pathogens resistant to azithromycin in vitro. Overall, adverse event rates were similar in both treatment groups. Conclusions
Azithromycin 1% ophthalmic solution in DuraSite showed statistically significant differences in clinical resolution and bacterial eradication rates when compared with vehicle. Because it was well tolerated in this population, it may be a viable treatment option for children and adults with bacterial conjunctivitis.
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