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Sponsored by: |
Inspire Pharmaceuticals |
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Information provided by: | Inspire Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00629590 |
The purpose of this study is to evaluate the safety and efficacy of AzaSite ophthalmic solution, 1% on signs and symptoms of blepharitis.
Condition | Intervention | Phase |
---|---|---|
Blepharitis |
Drug: AzaSite® |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment |
Official Title: | A Single-Center, Open-Label, Randomized Pilot Study of the Safety and Efficacy of AzaSite® Ophthalmic Solution, 1% in Combination With Mechanical Therapy Versus Mechanical Therapy Alone for Two Weeks in Subjects With Posterior Blepharitis |
Estimated Enrollment: | 20 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | July 2008 |
Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: AzaSite®
ophthalmic solution; 1 drop in each eye BID for two days, then 1 drop in each eye QD for ~12 days
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2: No Intervention |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Sponsor ( Inspire Pharmaceuticals ) |
Study ID Numbers: | 041-106 |
Study First Received: | February 21, 2008 |
Last Updated: | August 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00629590 |
Health Authority: | United States: Food and Drug Administration |
Azithromycin Eye Diseases Blepharitis |
Anti-Infective Agents Anti-Bacterial Agents Therapeutic Uses Eyelid Diseases Pharmacologic Actions |