Bacterial Infections Clinical Trial
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
Verified date | September 2011 |
Source | Merck Sharp & Dohme Corp. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of this study is to evaluate the drug concentrations of AzaSiteā¢ compared to Vigamox at various time points in conjunctiva tissue of healthy volunteers
Status | Completed |
Enrollment | 48 |
Est. completion date | |
Est. primary completion date | December 2007 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Merck Sharp & Dohme Corp. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assessment of Pharmacokinetic Parameters | Up to 24 hours | No | |
Primary | Assessment of Pharmacokinetic Parameters | Conjunctiva Concentration of Azithromycin and Moxifloxacin | Over 24 hours | No |
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