The Effects of Azithromycin Ophthalmic Solution, 1% Versus Placebo in Subjects With Blepharitis During a Four-Week Treatment Period (P08638)
- Conditions
- Blepharitis
- Interventions
- Drug: Placebo
- Registration Number
- NCT00894530
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 314
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Azithromycin ophthalmic solution, 1% - 2 Placebo -
- Primary Outcome Measures
Name Time Method Eyelid margin erythema Four weeks
- Secondary Outcome Measures
Name Time Method Signs and symptoms of Blepharitis One week, two weeks, three weeks, four weeks, six weeks, eight weeks
Trial Locations
- Locations (26)
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
Scroll for more (16 remaining)Schwartz Laser Eye Center🇺🇸Scottsdale, Arizona, United States