Blepharitis Clinical Trial
Verified date | October 2013 |
Source | Merck Sharp & Dohme Corp. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The objective of this study is to compare the safety and efficacy of azithromycin ophthalmic solution, 1% versus placebo over a four-week treatment period.
Status | Completed |
Enrollment | 314 |
Est. completion date | December 2009 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Have best corrected visual acuity in both eyes of at least +0.7 or better - If female, are non-pregnant or non-lactating - Have a current diagnosis of blepharitis in one or both eyes Exclusion Criteria: - Have lid structural abnormalities - 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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Sall Research Medical Center | Artesia | California |
United States | Sall Research Medical Center, Inc. | Artesia | California |
United States | Eastern Maine Medical Center | Bangor | Maine |
United States | Wohl Eye Center | Bloomingdale | Illinois |
United States | Hernando Eye Institute | Brooksville | Florida |
United States | Columbus Ophthalmology Associates | Columbus | Ohio |
United States | Ohio State University - College of Optometry | Columbus | Ohio |
United States | Park Ophthalmology | Durham | North Carolina |
United States | McDonald Eye Associates | Fayetteville | Arkansas |
United States | United Medical Research Company | Inglewood | California |
United States | Taustine Eye Center | Louisville | Kentucky |
United States | Ophthalmic Consultants of Long Island | Lynbrook | New York |
United States | Total Eye Care, PA | Memphis | Tennessee |
United States | Center for Excellence in Eye Care | Miami | Florida |
United States | North Valley Eye Medical Group | Mission Hills | California |
United States | Coastal Vision Medical Group | Newport Beach | California |
United States | Philadelphia Eye Associates | Philadelphia | Pennsylvania |
United States | Eye Clinics of South Texas | San Antonio | Texas |
United States | West Coast Eye Care | San Diego | California |
United States | Schwartz Laser Eye Center | Scottsdale | Arizona |
United States | David M. Ringel, DO, PA | Sewell | New Jersey |
United States | Ophthalmology Associates | St Louis | Missouri |
United States | Thomas John Vision Institute | Tinley Park | Illinois |
United States | Comprehensive Eye Care Ltd | Washington | Missouri |
United States | Brar-Parekh Eye Associates | West Paterson | New Jersey |
United States | Grene Vision Group | Wichita | Kansas |
Lead Sponsor | Collaborator |
---|---|
Merck Sharp & Dohme Corp. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Eyelid margin erythema | Four weeks | No | |
Secondary | Signs and symptoms of Blepharitis | One week, two weeks, three weeks, four weeks, six weeks, eight weeks | No |
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