Study of AzaSite Versus Vigamox in the Conjunctiva of Healthy Volunteers
Information source: Inspire Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bacterial Infections; Eye Infections
Intervention: AzaSite (azithromycin ophthalmic solution) (Drug); Vigamox (moxifloxacin hydrochloride ophthalmic solution) (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Inspire Pharmaceuticals Official(s) and/or principal investigator(s):
Reza Haque, Study Director, Affiliation: Inspire Pharmaceuticals
Summary
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
Clinical Details
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
Study design: Supportive Care, Randomized, Open Label, Parallel Assignment
Primary outcome: Assessment of pharmacokinetic parameters
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Have best corrected visual acuity of 0. 60 logMAR or better in each eye as measured
using Early Treatment of Diabetic Retinopathy Study chart
Exclusion Criteria:
- Have a known allergy and/or sensitivity to the test article(s) or its components or
any therapies associated with the trial
- Have active signs or symptoms of any clinically significant ocular disorder (other
than refractive disorders)
- Have a known bleeding disorder or history of bleeding complications after surgical or
dental procedures
- Take aspirin, or take any other blood thinners or anti-coagulants (e. g. warfarin)
including prescription, over the counter, or homeopathic therapies
- Have undergone any ocular surgical intervention within 3 months prior to Visit 1 or
anticipate having ocular surgery during the study
Locations and Contacts
Additional Information
Starting date: December 2007
Ending date: December 2007
Last updated: January 10, 2008
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