Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Tobramycin for Bacterial Conjunctivitis (C-01-401-004)
- Registration Number
- NCT00105469
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 743
- 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 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tobramycin Tobramycin 0.3% tobramycin AzaSite AzaSite 1.0% azithromycin in DuraSite
- Primary Outcome Measures
Name Time Method Number of Participants Who Achieved Clinical Resolution at Visit 3 Visit 3 (Day 6) 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 Number of Participants Who Achieved Bacterial Eradication at Visit 3 Visit 3 (Day 6) Bacterial eradication is defined as 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 (25)
Alan Shuster, MD
🇺🇸Jupiter, Florida, United States
Children's Eye Physicians
🇺🇸Littleton, Colorado, United States
Pasco Eye Institute
🇺🇸New Port Richey, Florida, United States
Advanced Eye Care
🇺🇸Panama City, Florida, United States
Tukoi Institute for Clinical Research
🇺🇸North Miami Beach, Florida, United States
The Eye Associates
🇺🇸Bradenton, Florida, United States
Presidential Eye Center
🇺🇸West Palm Beach, Florida, United States
Irving Weinberger, MD
🇺🇸Pittsburgh, Pennsylvania, United States
Renaissance Center
🇺🇸Birmingham, Alabama, United States
Eye Health Northwest
🇺🇸Portland, Oregon, United States
Mason Eye Institute
🇺🇸Columbia, Missouri, United States
Jon Fishburn, MD
🇺🇸Boise, Idaho, United States
Hutchinson Clinic
🇺🇸Hutchinson, Kansas, United States
Massachusetts Eye and Ear Infirmary
🇺🇸Boston, Massachusetts, United States
Medisphere Medical Research Center, LLC
🇺🇸Evansville, Indiana, United States
Ophthalmology Associates
🇺🇸Princeton, New Jersey, United States
Research Eye Care Center
🇺🇸Kansas City, Missouri, United States
Huntington Medical Group
🇺🇸Huntington Station, New York, United States
Cornerstone Eye Care
🇺🇸High Point, North Carolina, United States
Cottonwood Ophthalmology Associates
🇺🇸Murray, Utah, United States
Corona Research Consultants, Inc.
🇺🇸El Paso, Texas, United States
Southern Eye Associates, PA
🇺🇸Greenville, South Carolina, United States
Wenatchee Valley Medical Center
🇺🇸Wenatchee, Washington, United States
Rockwood Clinic, PS-Eye Center
🇺🇸Spokane, Washington, United States
Palm Beach Eye Associates
🇺🇸Atlantis, Florida, United States