At a glance
ClinicalIndex Comparison Record- ✓Male or female subject of any race, at least 1 year of age
- ✓Clinical diagnosis of acute bacterial conjunctivitis with mucopurulent or purulent conjunctival discharge and redness in at least one eye
- ✓Symptoms of bacterial conjunctivitis present for 3 days or less
- ✓Willing to discontinue contact lens wear for the duration of the study
- ✕Any uncontrolled, systemic, debilitating disease
- ✕Use of topical ophthalmic solutions including tear substitutes within 2 hours before and during the study
- ✕Use of topical ophthalmic anti-inflammatory agents within 48 hours before and during the study
- ✕Active upper respiratory tract infection
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Study to Evaluate the Clinical and Microbial Efficacy and Safety of 1.0 % AzaSite Compared to Vehicle in the Treatment of Bacterial Conjunctivitis
In Brief
A Phase 3 clinical trial evaluating AzaSite and Vehicle for Bacterial Conjunctivitis. Completed, enrolled 685 participants across 32 sites.
Detailed 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.
Study Details
Timeline
Interventions
1.0% AzaSite contains 1.0% azithromycin, sodium hydroxide, mannitol, poloxamer 407, citric acid anhydrous, sodium citrate, DuraSite® (polycarbophil, sodium chloride, EDTA disodium and water for injection) and benzalkonium chloride 0.003%. AzaSite was prescribed as a single topical drop to the infected eye(s) for 5 days, twice on the first two days (once in the morning and at bedtime) and once a day in the morning (between 7-10 AM) for the following three days.
Vehicle contains sodium hydroxide, mannitol, poloxamer 407, citric acid anhydrous, sodium citrate, DuraSite® (polycarbophil, sodium chloride, EDTA disodium and water for injection) and benzalkonium chloride 0.003%. Vehicle was prescribed as a single topical drop to the infected eye(s) for 5 days, twice on the first two days (once in the morning and at bedtime) and once a day in the morning (between 7-10 AM) for the following three days.