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Sponsored by: |
Inspire Pharmaceuticals |
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Information provided by: | Inspire Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00575367 |
The purpose of this study is to evaluate the drug concentrations of AzaSite compared to Vigamox in tears of healthy volunteers
Condition | Intervention | Phase |
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Bacterial Infections Eye Infections |
Drug: AzaSite (azithromycin ophthalmic solution) Drug: Vigamox (moxifloxacin hydrochloride ophthalmic solution) |
Phase IV |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Open Label, Dose Comparison, Parallel Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | A Single-Center, Open-Label, Randomized Study of the Pharmacokinetics of AzaSite Ophthalmic Solution Versus Vigamox in the Tears of Healthy Volunteers Following a Single Ocular Administration |
Estimated Enrollment: | 36 |
Study Start Date: | March 2008 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
2: Active Comparator |
Drug: AzaSite (azithromycin ophthalmic solution)
One drop ophthalmic solution at Visit 2
Drug: Vigamox (moxifloxacin hydrochloride ophthalmic solution)
One drop ophthalmic solution at Visit 2
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |
Mount Sinai School of Medicine | |
New York, New York, United States, 10029 |
Study Director: | Reza Haque, MD | Inspire Pharmaceuticals |
Responsible Party: | Inspire Pharmaceuticals, Inc. ( Saiid Davari, BS ) |
Study ID Numbers: | 041-101 |
Study First Received: | December 14, 2007 |
Last Updated: | November 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00575367 |
Health Authority: | United States: Food and Drug Administration |
Lacerations Bacterial Infections Moxifloxacin Azithromycin |
Eye Diseases Eye Infections Healthy |
Anti-Infective Agents Anti-Bacterial Agents Communicable Diseases |
Therapeutic Uses Infection Pharmacologic Actions |