The Effects of Azithromycin Ophthalmic Solution, 1% Versus Placebo in Subjects With Blepharitis During a Two-Week Treatment Period
NCT ID: NCT00892970
Last Updated: 2011-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
313 participants
INTERVENTIONAL
2009-04-30
2010-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Azithromycin ophthalmic solution, 1%
One drop in each eye twice a day for the first two days; then one drop in each eye once a day for 12 days
2
Placebo
One drop in each eye twice a day for the first two days; then one drop in each eye once a day for 12 days
Interventions
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Azithromycin ophthalmic solution, 1%
One drop in each eye twice a day for the first two days; then one drop in each eye once a day for 12 days
Placebo
One drop in each eye twice a day for the first two days; then one drop in each eye once a day for 12 days
Eligibility Criteria
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Inclusion Criteria
* If female, are non-pregnant or non-lactating
* Have a current diagnosis of blepharitis in one or both eyes
Exclusion Criteria
* Have suspected ocular fungal or viral infection
* Have practiced warm compress therapy within 14 days prior to Visit 2
* Unable to withhold the use of contact lenses during the treatment or follow-up periods
* Unable to withhold the use of ocular cosmetic products within 24 hours prior to study visits
* Have had penetrating intraocular surgery within 90 days prior to Visit 2
* Have had ocular surface surgery within the past year prior to Visit 2
* Have a serious medical condition which could confound study assessments
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Inspire
Principal Investigators
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Reza Haque, MD, PhD
Role: STUDY_CHAIR
Medical Monitor, Inspire
Locations
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Jones Eye Institute
Little Rock, Arkansas, United States
Sall Medical Research Center
Artesia, California, United States
Milton Hom, OD
Azusa, California, United States
The Jules Stein Eye Institute UCLA Laser Refractive Center
Los Angeles, California, United States
North Valley Eye Medical Group
Mission Hills, California, United States
David Wirta, MD, Inc.
Newport Beach, California, United States
North Bay Eye Associates
Petaluma, California, United States
West Coast Eye Care
San Diego, California, United States
Wolstan Eye Associates
Torrence, California, United States
Eye Center - A Medical and Surgical Group
Hamden, Connecticut, United States
Florida Eye Microsurgical Institute
Boynton Beach, Florida, United States
Eye Centers of Florida
Fort Myers, Florida, United States
NorthShore University HealthSystems
Glenview, Illinois, United States
Chicago Cornea Consultants
Hoffman Estates, Illinois, United States
Indiana University School of Medicine, Ophthalmology Dept.
Indianapolis, Indiana, United States
Eye Physicians and Surgeons, LLP
Iowa City, Iowa, United States
Koffler Vision Group
Lexington, Kentucky, United States
Wilmer Eye Institute, Johns Hopkins Hospital
Baltimore, Maryland, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States
Minnesota Eye Consultants
Minneapolis, Minnesota, United States
Ophthalmology Associates
St Louis, Missouri, United States
Ophthalmology Consultants
St Louis, Missouri, United States
Brar-Parekh Eye Associates
Woodland Park, New Jersey, United States
South Shore Eye Care
Wantagh, New York, United States
Mundorf Eye Center
Charlotte, North Carolina, United States
TLC Laser Eye Center
Greensboro, North Carolina, United States
Cornerstone Eye Care
High Point, North Carolina, United States
Abrams Eye Center
Cleveland, Ohio, United States
Bucci Laser Vision Institute
Wilkes-Barre, Pennsylvania, United States
McCabe Vision Center
Murfreesboro, Tennessee, United States
Eye Clinic of Austin
Austin, Texas, United States
See Clearly Vision Group
McLean, Virginia, United States
Virginia Eye Consultants
Norfolk, Virginia, United States
Countries
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Other Identifiers
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P08639
Identifier Type: -
Identifier Source: secondary_id
044-101
Identifier Type: -
Identifier Source: org_study_id