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Sponsored by: |
Inspire Pharmaceuticals |
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Information provided by: | Inspire Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00564447 |
The purpose of this study is to evaluate the drug concentrations of AzaSite™ compared to Vigamox at various time points in conjunctiva tissue 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, Parallel Assignment |
Official Title: | A Single-Center, Open-Label, Randomized Study of the Pharmacokinetics of AzaSite Ophthalmic Solution Versus Vigamox in the Conjunctiva of Healthy Volunteers Following a Single Ocular Administration |
Enrollment: | 48 |
Study Start Date: | December 2007 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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2: Active Comparator |
Drug: AzaSite (azithromycin ophthalmic solution)
One drop ophthalmic solution at Visit 2 (Day 0)
Drug: Vigamox (moxifloxacin hydrochloride ophthalmic solution)
One drop ophthalmic solution at Visit 2 (Day 0)
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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:
Responsible Party: | Inspire Pharmaceuticals, Inc. ( Saiid Davari ) |
Study ID Numbers: | 041-102 |
Study First Received: | November 20, 2007 |
Last Updated: | November 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00564447 |
Health Authority: | United States: Food and Drug Administration |
Bacterial Infections Moxifloxacin Azithromycin |
Eye Diseases Eye Infections Healthy |
Anti-Infective Agents Anti-Bacterial Agents Communicable Diseases |
Therapeutic Uses Infection Pharmacologic Actions |