Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Vehicle for Bacterial Conjunctivitis (C-01-401-003)

Summary

The purpose of this study is to evaluate the clinical and microbial efficacy and safety of AzaSite compared to vehicle for bacterial conjunctivitis. Adults and children one year of age and older with bacterial conjunctivitis in at least one eye may be eligible. Subjects will be randomly assigned to receive either 1.0 % AzaSite or Vehicle. Three visits will be required for this study.

Timeline

Start

2004-07

Primary completion

2006-01

Completion

2006-01

Outcome

Met primary endpoint

paper Clinical resolution with azithromycin ophthalmic solution was statistically significant compared with that of vehicle (P = .030) at visit 3. PMID 18374301 ↗

Publications

• Abelson MB, Heller W, Shapiro AM, Si E, Hsu P, Bowman LM; AzaSite Clinical Study Group. Clinical cure of bacterial conjunctivitis with azithromycin 1%: vehicle-controlled, double-masked clinical trial. Am J Ophthalmol. 2008 Jun;145(6):959-65. doi: 10.1016/j.ajo.2008.01.019. Epub 2008 Mar 28.

Drugs

Indications