Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Tobramycin for Bacterial Conjunctivitis (C-01-401-004)
Bacterial Conjunctivitis
About this trial
This is an interventional treatment trial for Bacterial Conjunctivitis focused on measuring Bacterial Conjunctivitis, Pink Eye, Conjunctivitis, Eye Infection
Eligibility Criteria
Inclusion Criteria: Male or female subject, of any race, who is at least 1 year of age. Subjects must have a clinical diagnosis of acute bacterial conjunctivitis and exhibit mucopurulent or purulent conjunctival discharge (crusty or sticky eyelids, globular and yellow discharge) and redness in at least one eye. The symptoms of bacterial conjunctivitis must be present for 3 days (approximately 72 hours) or less. Must be willing to discontinue contact lens wear for the duration of the study. Exclusion Criteria: Any uncontrolled systemic disease or debilitating disease. Use of topical ophthalmic solutions including tear substitutes within 2 hours before and during the study. Use of any topical ophthalmic anti-inflammatory agents within 48 hours before and during study. Any active upper respiratory tract infection. Pregnant or nursing females. Use of any antibiotic (topical or systemic) within 72 hours of enrollment.
Sites / Locations
- Renaissance Center
- Children's Eye Physicians
- Palm Beach Eye Associates
- The Eye Associates
- Alan Shuster, MD
- Pasco Eye Institute
- Tukoi Institute for Clinical Research
- Advanced Eye Care
- Presidential Eye Center
- Jon Fishburn, MD
- Medisphere Medical Research Center, LLC
- Hutchinson Clinic
- Massachusetts Eye and Ear Infirmary
- Mason Eye Institute
- Ophthalmology Associates
- Research Eye Care Center
- Ophthalmology Associates
- Huntington Medical Group
- Cornerstone Eye Care
- Eye Health Northwest
- Irving Weinberger, MD
- Southern Eye Associates, PA
- Corona Research Consultants, Inc.
- Cottonwood Ophthalmology Associates
- Rockwood Clinic, PS-Eye Center
- Wenatchee Valley Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
AzaSite
Tobramycin
1.0% azithromycin in DuraSite
0.3% tobramycin