Safety and Efficacy Study of AzaSite® in Subjects With Blepharitis
- Registration Number
- NCT00629941
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
The purpose of this study is to evaluate the safety and efficacy of AzaSite® ophthalmic solution, 1% on signs \& symptoms of blepharitis and tear cytokine and eyelid bacterial load levels
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
Inclusion Criteria
- Diagnosis of moderate to severe chronic blepharitis
- If female of childbearing potential, are non-pregnant and non-lactating
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Exclusion Criteria
- Had ocular surface surgery (LASIK, refractive, etc.) within the past year
- Unwilling to discontinue use of contact lenses during the study
- Have glaucoma
- Unable or unwilling to withhold the use of lid scrubs during the study
- Have a serious systemic disease or uncontrolled medical condition that in the judgment of the investigator could confound study assessments or limit compliance
- Currently using any preserved topical ocular medications (with the exception of unpreserved tear substitutes) at the time of entry into the study or during study participation
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 AzaSite® -
- Primary Outcome Measures
Name Time Method Change in clinical signs and symptoms associated with blepharitis 8 weeks
- Secondary Outcome Measures
Name Time Method Standard ocular safety assessments 4 weeks Change in tear cytokine and eyelid bacterial load levels 4 Weeks
Trial Locations
- Locations (2)
Central Maine Eye Care
🇺🇸Lewiston, Maine, United States
Ophthalmic Research Associates
🇺🇸Andover, Massachusetts, United States