Clinical Trial: Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Vehicle for Bacterial Conjunctivitis (C-01-401-003)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Study to Evaluate the Clinical and Microbial Efficacy and Safety of 1.0 % AzaSite Compared to Vehicle in the Treatment of Bacterial Conjunctivitis
Brief 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.
Detailed Summary:
Sponsor: Merck Sharp & Dohme Corp.
Current Primary Outcome: Participants Who Achieved Clinical Resolution [ Time Frame: Visit 3 (Days 6-7) ]
Original Primary Outcome:
- Clinical assessments of ocular discharge
- Bacteriological cultures
Current Secondary Outcome: Participants Who Achieved Bacteriological Eradication [ Time Frame: Visit 3 (Day 6-7) ]
Original Secondary Outcome:
- Adverse events
- Visual acuity
- Biomicroscopy
- Ophthalmoscopy
Information By: Merck Sharp & Dohme Corp.
Dates:
Date Received: March 15, 2005
Date Started: July 2004
Date Completion:
Last Updated: October 29, 2013
Last Verified: October 2013