Status:
COMPLETED
Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Tobramycin for Bacterial Conjunctivitis (C-01-401-004)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Bacterial Conjunctivitis
Eligibility:
All Genders
1+ years
Phase:
PHASE3
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 wi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2005
Estimated Enrollment :
743 Patients enrolled
Trial Details
Trial ID
NCT00105469
Start Date
July 1 2004
End Date
October 1 2005
Last Update
December 16 2013
Active Locations (26)
Enter a location and click search to find clinical trials sorted by distance.
1
Renaissance Center
Birmingham, Alabama, United States, 35205
2
Children's Eye Physicians
Littleton, Colorado, United States, 80122
3
Palm Beach Eye Associates
Atlantis, Florida, United States, 33462
4
The Eye Associates
Bradenton, Florida, United States, 34209