Safety and Efficacy Pilot Study of AzaSite® (Azithromycin) in Subjects With Blepharitis
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: 1
|
Drug: AzaSite®
ophthalmic solution; 1 drop in each eye BID for two days, then 1 drop in each eye QD for ~26 days
|
No Intervention: 2
|
Outcome Measures
Primary Outcome Measures
- change in clinical signs and symptoms associated with blepharitis [4 weeks]
Secondary Outcome Measures
- standard ocular safety assessments [4 weeks]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Sall Research Medical Center | Artesia | California | United States | 90701 |
2 | North Valley Eye Medical Group | Mission Hills | California | United States | 91345 |
3 | Center for Excellence in Eye Care | Miami | Florida | United States | 33176 |
4 | Kentuckiana Institute for Eye Research | Louisville | Kentucky | United States | 40207 |
5 | Tauber Eye Center | Kansas City | Missouri | United States | 64111 |
6 | Silverstein Eye Centers | Kansas City | Missouri | United States | 64133 |
7 | South Shore Eye Care, LLP | Wantagh | New York | United States | 11793 |
8 | Toyos Clinic | Jackson | Tennessee | United States | 38301 |
9 | Corona Research Consultants, Inc. | El Paso | Texas | United States | 79904 |
Sponsors and Collaborators
- Merck Sharp & Dohme Corp.
Investigators
- Study Director: Reza Haque, MD, Sponsor GmbH
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 041-105
- P08651