Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Tobramycin for Bacterial Conjunctivitis (C-01-401-004)
NCT ID: NCT00105469
Last Updated: 2013-12-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
743 participants
INTERVENTIONAL
2004-07-31
2005-10-31
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
TRIPLE
Study Groups
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AzaSite
1.0% azithromycin in DuraSite
AzaSite
AzaSite ophthalmic solution; one topical drop to the infected eye or eyes twice daily (in the morning and at bedtime) on Days 1 and 2 followed by once daily (in the morning between 7 and 10am) on Days 3 through 5.
Tobramycin
0.3% tobramycin
Tobramycin
Tobramycin ophthalmic solution; one topical drop to the infected eye or eyes four times daily at 4 to 6 hour intervals (first dose in the morning between 7 and 10am) for 5 days.
Interventions
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AzaSite
AzaSite ophthalmic solution; one topical drop to the infected eye or eyes twice daily (in the morning and at bedtime) on Days 1 and 2 followed by once daily (in the morning between 7 and 10am) on Days 3 through 5.
Tobramycin
Tobramycin ophthalmic solution; one topical drop to the infected eye or eyes four times daily at 4 to 6 hour intervals (first dose in the morning between 7 and 10am) for 5 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 study.
* Any active upper respiratory tract infection.
* Pregnant or nursing females.
* Use of any antibiotic (topical or systemic) within 72 hours of enrollment.
1 Year
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Merck Sharp & Dohme Corp
Locations
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Renaissance Center
Birmingham, Alabama, United States
Children's Eye Physicians
Littleton, Colorado, United States
Palm Beach Eye Associates
Atlantis, Florida, United States
The Eye Associates
Bradenton, Florida, United States
Alan Shuster, MD
Jupiter, Florida, United States
Pasco Eye Institute
New Port Richey, Florida, United States
Tukoi Institute for Clinical Research
North Miami Beach, Florida, United States
Advanced Eye Care
Panama City, Florida, United States
Presidential Eye Center
West Palm Beach, Florida, United States
Jon Fishburn, MD
Boise, Idaho, United States
Medisphere Medical Research Center, LLC
Evansville, Indiana, United States
Hutchinson Clinic
Hutchinson, Kansas, United States
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States
Mason Eye Institute
Columbia, Missouri, United States
Ophthalmology Associates
Creve Coeur, Missouri, United States
Research Eye Care Center
Kansas City, Missouri, United States
Ophthalmology Associates
Princeton, New Jersey, United States
Huntington Medical Group
Huntington Station, New York, United States
Cornerstone Eye Care
High Point, North Carolina, United States
Eye Health Northwest
Portland, Oregon, United States
Irving Weinberger, MD
Pittsburgh, Pennsylvania, United States
Southern Eye Associates, PA
Greenville, South Carolina, United States
Corona Research Consultants, Inc.
El Paso, Texas, United States
Cottonwood Ophthalmology Associates
Murray, Utah, United States
Rockwood Clinic, PS-Eye Center
Spokane, Washington, United States
Wenatchee Valley Medical Center
Wenatchee, Washington, United States
Countries
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References
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Protzko E, Bowman L, Abelson M, Shapiro A; AzaSite Clinical Study Group. Phase 3 safety comparisons for 1.0% azithromycin in polymeric mucoadhesive eye drops versus 0.3% tobramycin eye drops for bacterial conjunctivitis. Invest Ophthalmol Vis Sci. 2007 Aug;48(8):3425-9. doi: 10.1167/iovs.06-1413.
Related Links
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Related Info
Other Identifiers
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C-01-401-004
Identifier Type: -
Identifier Source: secondary_id
P08633
Identifier Type: -
Identifier Source: org_study_id