Safety and Efficacy Study of AzaSite® in Subjects With Blepharitis
Status and phase
Completed
Phase 4
Conditions
Blepharitis
Treatments
Drug: AzaSite®
Details and patient eligibility
About
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
Enrollment
25 estimated patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- Diagnosis of moderate to severe chronic blepharitis
- If female of childbearing potential, are non-pregnant and non-lactating
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
Trial design
Primary purpose
Treatment
Allocation
N/A
Interventional model
Single Group Assignment
Masking
None (Open label)
25 participants in 1 patient group
1
Experimental group
Treatment:
Drug: AzaSite®
Trial contacts and locations
2
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Data sourced from clinicaltrials.gov
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