At a glance
ClinicalIndex Comparison Record- ✓Male or female of any race, at least 1 year of age
- ✓Clinical diagnosis of acute bacterial conjunctivitis with mucopurulent or purulent discharge and redness in at least one eye
- ✓Symptoms present for 3 days (approximately 72 hours) or less
- ✓Willing to discontinue contact lens wear for the duration of the study
- ✕Uncontrolled or debilitating systemic disease
- ✕Use of topical ophthalmic solutions (including tear substitutes) within 2 hours before enrollment and during the study
- ✕Use of topical ophthalmic anti-inflammatory agents within 48 hours before enrollment and during 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 0.3% Tobramycin Ophthalmic Solution in the Treatment of Bacterial Conjunctivitis
In Brief
A Phase 3 clinical trial evaluating AzaSite and Tobramycin for Bacterial Conjunctivitis. Completed, enrolled 743 participants across 26 sites.
Detailed Summary
The purpose of this study is to evaluate the clinical and microbial efficacy and safety of AzaSite compared to tobramycin for bacterial conjunctivitis. Adults and children one year of age and older with bacterial conjunctivitis in at least one eye are eligible. Subjects will be randomly assigned to the AzaSite group or Tobramycin group. Three visits will be required for the study.
Study Details
Timeline
Interventions
AzaSite ophthalmic solution; one topical drop to the infected eye or eyes twice daily (in the morning and at bedtime) on Days 1 and 2 followed by once daily (in the morning between 7 and 10am) on Days 3 through 5.
Tobramycin ophthalmic solution; one topical drop to the infected eye or eyes four times daily at 4 to 6 hour intervals (first dose in the morning between 7 and 10am) for 5 days.