Status:
COMPLETED
Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Vehicle for Bacterial Conjunctivitis (C-01-401-003)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Bacterial Conjunctivitis
Eligibility:
All Genders
12+ years
Phase:
PHASE3
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 ...
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, 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
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2006
Estimated Enrollment :
685 Patients enrolled
Trial Details
Trial ID
NCT00105534
Start Date
July 1 2004
End Date
January 1 2006
Last Update
November 21 2013
Active Locations (32)
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1
I Care! Eye Care!
Flagstaff, Arizona, United States, 86001
2
Rx For Life, Inc.
Cudahy, California, United States, 90201
3
North Bay Eye Associates
Petaluma and Santa Rosa, California, United States, 95401
4
San Diego Eye and Laser Center
San Diego, California, United States, 92123