Blepharitis
Conditions
Brief summary
The purpose of this study is to evaluate the safety and efficacy of AzaSite® ophthalmic solution, 1% on signs and symptoms of blepharitis.
Interventions
DRUGAzaSite®
ophthalmic solution; 1 drop in each eye BID for two days, then 1 drop in each eye QD for \ 26 days
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 the 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in clinical signs and symptoms associated with blepharitis | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| standard ocular safety assessments | 4 weeks |
Countries
United States
Outcome results
None listed