Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Vehicle for Bacterial Conjunctivitis (C-01-401-003)
- Registration Number
- NCT00105534
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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 Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 685
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AzaSite AzaSite - Vehicle Vehicle -
- Primary Outcome Measures
Name Time Method Participants Who Achieved Clinical Resolution Visit 3 (Days 6-7) Clinical Resolution is defined as absence of all three clinical signs: ocular discharge, bulbar conjunctival injection, and palpebral conjunctival injection.
- Secondary Outcome Measures
Name Time Method Participants Who Achieved Bacteriological Eradication Visit 3 (Day 6-7) Bacterial eradication is defined as the eradication of the causative pathogens as indicated by the absence of growth (0 colony forming units/mL) of the original infecting organism(s).
Trial Locations
- Locations (32)
Taustine Eye Center
🇺🇸Louisville, Kentucky, United States
Charlotte Eye, Ear, Nose, and Throat
🇺🇸Charlotte, North Carolina, United States
Precision Eye Care
🇺🇸Huntington, New York, United States
University Eye Surgeons
🇺🇸Maryville, Tennessee, United States
Abrams Eye Center
🇺🇸Cleveland, Ohio, United States
Advanced Eyecare and Laser Center
🇺🇸Runnemede, New Jersey, United States
Bossier Optical Inc.
🇺🇸Bossier City, Louisiana, United States
The Louisiana Eye Center
🇺🇸Zachary, Louisiana, United States
Bohn and Joseph Eye Center
🇺🇸Lafayette, Louisiana, United States
Horizon Eye Center
🇺🇸Charlotte, North Carolina, United States
I Care! Eye Care!
🇺🇸Flagstaff, Arizona, United States
Rx For Life, Inc.
🇺🇸Cudahy, California, United States
San Diego Eye and Laser Center
🇺🇸San Diego, California, United States
North Bay Eye Associates
🇺🇸Petaluma and Santa Rosa, California, United States
Western States Clinical Research
🇺🇸Wheat Ridge, Colorado, United States
Opticare Eye Health Center
🇺🇸Waterbury, Connecticut, United States
Mississippi Eye Associates
🇺🇸Ocean Springs, Mississippi, United States
Total Eye Care, PA
🇺🇸Memphis, Tennessee, United States
Bend Memorial Clinic
🇺🇸Bend, Oregon, United States
International Eye Center
🇺🇸Tampa, Florida, United States
Sun Research Institute
🇺🇸San Antonio, Texas, United States
Metaclin Research, Inc.
🇺🇸Austin, Texas, United States
Mark Mayo, MD
🇺🇸Pasadena, Texas, United States
Welborn Clinic and Welborn Clinic East
🇺🇸Evansville, Indiana, United States
Physicians Eye Associates & Cosmetic Laser
🇺🇸Houston, Texas, United States
Advanced Healthcare, SC
🇺🇸Milwaukee, Wisconsin, United States
Eye Associates
🇺🇸Nashville, Tennessee, United States
Marc Sanders, MD
🇺🇸Houston, Texas, United States
Cottonwood Eye and Laser Clinic
🇺🇸Salt Lake City, Utah, United States
Clinical Research Laboratories
🇺🇸Piscataway, New Jersey, United States
Mountain View Eye Center
🇺🇸Layton, Utah, United States
Groat Eyecare Associates
🇺🇸Greensboro, North Carolina, United States