The Effects of Azithromycin Ophthalmic Solution, 1% Versus Placebo in Subjects With Blepharitis During a Four-Week Treatment Period (P08638)
NCT ID: NCT00894530
Last Updated: 2013-11-21
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
314 participants
INTERVENTIONAL
2009-05-31
2009-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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 26 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 26 days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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 26 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 26 days
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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
Meet the organizations funding or collaborating on the study and learn about their roles.
Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Reza Haque, MD,PhD
Role: STUDY_CHAIR
Medical Monitor, Inspire
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Schwartz Laser Eye Center
Scottsdale, Arizona, United States
McDonald Eye Associates
Fayetteville, Arkansas, United States
Sall Research Medical Center, Inc.
Artesia, California, United States
Sall Research Medical Center
Artesia, California, United States
United Medical Research Company
Inglewood, California, United States
North Valley Eye Medical Group
Mission Hills, California, United States
Coastal Vision Medical Group
Newport Beach, California, United States
West Coast Eye Care
San Diego, California, United States
Hernando Eye Institute
Brooksville, Florida, United States
Center for Excellence in Eye Care
Miami, Florida, United States
Wohl Eye Center
Bloomingdale, Illinois, United States
Thomas John Vision Institute
Tinley Park, Illinois, United States
Grene Vision Group
Wichita, Kansas, United States
Taustine Eye Center
Louisville, Kentucky, United States
Eastern Maine Medical Center
Bangor, Maine, United States
Ophthalmology Associates
St Louis, Missouri, United States
Comprehensive Eye Care Ltd
Washington, Missouri, United States
David M. Ringel, DO, PA
Sewell, New Jersey, United States
Brar-Parekh Eye Associates
Woodland Park, New Jersey, United States
Ophthalmic Consultants of Long Island
Lynbrook, New York, United States
Park Ophthalmology
Durham, North Carolina, United States
Ohio State University - College of Optometry
Columbus, Ohio, United States
Columbus Ophthalmology Associates
Columbus, Ohio, United States
Philadelphia Eye Associates
Philadelphia, Pennsylvania, United States
Total Eye Care, PA
Memphis, Tennessee, United States
Eye Clinics of South Texas
San Antonio, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
044-102
Identifier Type: -
Identifier Source: secondary_id
P08638
Identifier Type: -
Identifier Source: org_study_id