Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Vehicle for Bacterial Conjunctivitis (C-01-401-003)
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|ClinicalTrials.gov Identifier: NCT00105534|
Recruitment Status : Completed
First Posted : March 16, 2005
Results First Posted : October 27, 2011
Last Update Posted : November 21, 2013
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|Condition or disease||Intervention/treatment||Phase|
|Bacterial Conjunctivitis||Drug: AzaSite Other: Vehicle||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||685 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Study to Evaluate the Clinical and Microbial Efficacy and Safety of 1.0 % AzaSite Compared to Vehicle in the Treatment of Bacterial Conjunctivitis|
|Study Start Date :||July 2004|
|Actual Primary Completion Date :||January 2006|
|Actual Study Completion Date :||January 2006|
1.0% AzaSite contains 1.0% azithromycin, sodium hydroxide, mannitol, poloxamer 407, citric acid anhydrous, sodium citrate, DuraSite® (polycarbophil, sodium chloride, EDTA disodium and water for injection) and benzalkonium chloride 0.003%. AzaSite was prescribed as a single topical drop to the infected
eye(s) for 5 days, twice on the first two days (once in the morning and at bedtime) and once a day in the morning (between 7-10 AM) for the following three days.
|Sham Comparator: Vehicle||
Vehicle contains sodium hydroxide, mannitol, poloxamer 407, citric acid anhydrous, sodium citrate, DuraSite® (polycarbophil, sodium chloride, EDTA disodium and water for injection) and benzalkonium chloride 0.003%. Vehicle was prescribed as a single topical drop to the infected eye(s) for 5 days, twice on the first two days (once in the morning and at bedtime) and once a day in the morning (between 7-10 AM) for the following three days.
- Participants Who Achieved Clinical Resolution [ Time Frame: 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.
- Participants Who Achieved Bacteriological Eradication [ Time Frame: 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).
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|Ages Eligible for Study:||12 Months and older (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00105534
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Merck Sharp & Dohme LLC|
|Other Study ID Numbers:||
|First Posted:||March 16, 2005 Key Record Dates|
|Results First Posted:||October 27, 2011|
|Last Update Posted:||November 21, 2013|
|Last Verified:||October 2013|
Eye Infections, Bacterial
Bacterial Infections and Mycoses