Study of AzaSite (Azithromycin) Versus Vigamox in the Conjunctiva of Healthy Volunteers
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...
Brief Summary
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”
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
- Study Type: Interventional
- Study Design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
- Study Primary Completion Date: December 2007
Intervention(s) in this Clinical Trial
- Drug: Azithromycin
- azithromycin topical solution 1% given as a single drop in a single eye
- Drug: Moxifloxacin
- Moxifloxacin topical solution given as a single drop in a single eye
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: Azithromycin-30 minutes Post dose
- Experimental: Azithromycin-2 hours post dose
- Experimental: Azithromycin-12 hours post dose
- Experimental: Azithromycin-24 hours post dose
- Experimental: Moxifloxacin-30 minutes post dose
- Experimental: Moxifloxacin-2 hours post dose
- Experimental: Moxifloxacin-12 hours post dose
- Experimental: Moxafloxacin-24 hours post dose
Outcome Measures for this Clinical Trial
Primary Measures
- Assessment of Pharmacokinetic Parameters
- Time Frame: Up to 24 hours
Safety Issue?: No
- Time Frame: Up to 24 hours
- Assessment of Pharmacokinetic Parameters
- Time Frame: Over 24 hours
Safety Issue?: No
- Time Frame: Over 24 hours
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Investigator Information
Lead Investigator: Merck Industry
Overall Clinical Trial Officials and Contacts
Reza Haque Study Director Merck
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00564447
Study ID Number: 041-102
ClinicalTrials.gov Identifier: NCT00564447
Health Authority: United States: Food and Drug Administration
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00564447
