Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Vehicle for Bacterial Conjunctivitis (C-01-401-003)
Bacterial Conjunctivitis
About this trial
This is an interventional treatment trial for Bacterial Conjunctivitis focused on measuring Bacterial Conjunctivitis, Pink Eye, Conjunctivitis, Eye Infection, Eye Discharge
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, 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 the 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
- I Care! Eye Care!
- Rx For Life, Inc.
- North Bay Eye Associates
- San Diego Eye and Laser Center
- Western States Clinical Research
- Opticare Eye Health Center
- International Eye Center
- Welborn Clinic and Welborn Clinic East
- Taustine Eye Center
- Bossier Optical Inc.
- Bohn and Joseph Eye Center
- The Louisiana Eye Center
- Mississippi Eye Associates
- Clinical Research Laboratories
- Advanced Eyecare and Laser Center
- Precision Eye Care
- Charlotte Eye, Ear, Nose, and Throat
- Horizon Eye Center
- Groat Eyecare Associates
- Abrams Eye Center
- Bend Memorial Clinic
- University Eye Surgeons
- Total Eye Care, PA
- Eye Associates
- Metaclin Research, Inc.
- Physicians Eye Associates & Cosmetic Laser
- Marc Sanders, MD
- Mark Mayo, MD
- Sun Research Institute
- Mountain View Eye Center
- Cottonwood Eye and Laser Clinic
- Advanced Healthcare, SC
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
AzaSite
Vehicle