Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Inspire Pharmaceuticals |
---|---|
Information provided by: | Inspire Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00575380 |
The purpose of this study is to evaluate the drug concentrations in the conjunctiva and aqueous humor of AzaSite™ compared to Vigamox® in subjects undergoing routine cataract surgery
Condition | Intervention | Phase |
---|---|---|
Bacterial Infections Eye Infections Cataract Extraction |
Drug: AzaSite (azithromycin ophthalmic solution) Drug: Vigamox (moxifloxacin hydrochloride ophthalmic solution) |
Phase IV |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Open Label, Parallel Assignment, Pharmacokinetics Study |
Official Title: | A Multi-Center, Open-Label, Randomized Study of the Pharmacokinetics of Azithromycin Versus Moxifloxacin in Conjunctiva and Aqueous Humor Following Single or Multiple Ocular Administration of AzaSite Ophthalmic Solution, 1% or Vigamox in Subjects Undergoing Routine Cataract Surgery |
Estimated Enrollment: | 120 |
Study Start Date: | December 2007 |
Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
2: Active Comparator |
Drug: AzaSite (azithromycin ophthalmic solution)
One drop three times a day for two days and once a day for the next five days
Drug: Vigamox (moxifloxacin hydrochloride ophthalmic solution)
One drop three times a day for seven days
|
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Arizona | |
Cornea Consultants of Arizone | |
Phoenix, Arizona, United States, 85032 | |
United States, Arkansas | |
Eye Care Arkansas | |
Little Rock, Arkansas, United States, 72205 | |
United States, California | |
North Valley Eye Medical Group | |
Mission Hills, California, United States, 91345 | |
United States, Florida | |
Eye Center of North Florida | |
Panama City, Florida, United States, 32405 | |
Center for Excellence in Eye Care | |
Miami, Florida, United States, 33176 | |
United States, Georgia | |
Coastal Research Associates, LLC | |
Atlanta, Georgia, United States, 30339 | |
United States, Kentucky | |
Kentuckiana Institute for Eye Research | |
Louisville, Kentucky, United States, 40207 | |
United States, Missouri | |
Ophthalmology Associates | |
St. Louis, Missouri, United States, 63131 | |
United States, New York | |
Ophthalmic Consultants of Long Island | |
Rockville Centre, New York, United States, 11563 | |
United States, Pennsylvania | |
Eye Care Specialists | |
Kingston, Pennsylvania, United States, 18704 | |
United States, South Carolina | |
Glaucoma Consultants and Center for Eye Research | |
Mount Pleasant, South Carolina, United States, 29464 | |
Medical University of South Carolina | |
Charleston, South Carolina, United States, 29464 | |
United States, Texas | |
Corona Research Consultants | |
El Paso, Texas, United States, 79904 |
Study Director: | Reza Haque, MD | Inspire Pharmaceuticals |
Responsible Party: | Inspire Pharmaceuticals ( Mike Schiewe ) |
Study ID Numbers: | 041-103 |
Study First Received: | December 12, 2007 |
Last Updated: | May 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00575380 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Bacterial Infections Anti-Infective Agents Anti-Bacterial Agents Moxifloxacin Azithromycin |
Eye Diseases Cataract Eye Infections Lens Diseases |
Bacterial Infections Communicable Diseases Anti-Infective Agents Eye Diseases Eye Infections Lens Diseases Infection |
Pharmacologic Actions Anti-Bacterial Agents Moxifloxacin Cataract Azithromycin Therapeutic Uses |