Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Vehicle for Bacterial Conjunctivitis (C-01-401-003)
NCT ID: NCT00105534
Last Updated: 2013-11-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
685 participants
INTERVENTIONAL
2004-07-31
2006-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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AzaSite
AzaSite
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.
Vehicle
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.
Interventions
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AzaSite
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
12 Months
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Locations
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I Care! Eye Care!
Flagstaff, Arizona, United States
Rx For Life, Inc.
Cudahy, California, United States
North Bay Eye Associates
Petaluma and Santa Rosa, California, United States
San Diego Eye and Laser Center
San Diego, California, United States
Western States Clinical Research
Wheat Ridge, Colorado, United States
Opticare Eye Health Center
Waterbury, Connecticut, United States
International Eye Center
Tampa, Florida, United States
Welborn Clinic and Welborn Clinic East
Evansville, Indiana, United States
Taustine Eye Center
Louisville, Kentucky, United States
Bossier Optical Inc.
Bossier City, Louisiana, United States
Bohn and Joseph Eye Center
Lafayette, Louisiana, United States
The Louisiana Eye Center
Zachary, Louisiana, United States
Mississippi Eye Associates
Ocean Springs, Mississippi, United States
Clinical Research Laboratories
Piscataway, New Jersey, United States
Advanced Eyecare and Laser Center
Runnemede, New Jersey, United States
Precision Eye Care
Huntington, New York, United States
Charlotte Eye, Ear, Nose, and Throat
Charlotte, North Carolina, United States
Horizon Eye Center
Charlotte, North Carolina, United States
Groat Eyecare Associates
Greensboro, North Carolina, United States
Abrams Eye Center
Cleveland, Ohio, United States
Bend Memorial Clinic
Bend, Oregon, United States
University Eye Surgeons
Maryville, Tennessee, United States
Total Eye Care, PA
Memphis, Tennessee, United States
Eye Associates
Nashville, Tennessee, United States
Metaclin Research, Inc.
Austin, Texas, United States
Physicians Eye Associates & Cosmetic Laser
Houston, Texas, United States
Marc Sanders, MD
Houston, Texas, United States
Mark Mayo, MD
Pasadena, Texas, United States
Sun Research Institute
San Antonio, Texas, United States
Mountain View Eye Center
Layton, Utah, United States
Cottonwood Eye and Laser Clinic
Salt Lake City, Utah, United States
Advanced Healthcare, SC
Milwaukee, Wisconsin, United States
Countries
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References
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Abelson MB, Heller W, Shapiro AM, Si E, Hsu P, Bowman LM; AzaSite Clinical Study Group. Clinical cure of bacterial conjunctivitis with azithromycin 1%: vehicle-controlled, double-masked clinical trial. Am J Ophthalmol. 2008 Jun;145(6):959-65. doi: 10.1016/j.ajo.2008.01.019. Epub 2008 Mar 28.
Related Links
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Related Info
Other Identifiers
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C-01-401-003
Identifier Type: -
Identifier Source: secondary_id
P08635
Identifier Type: -
Identifier Source: org_study_id