Study of AzaSite (Azithromycin) Versus Vigamox in the Conjunctiva of Healthy Volunteers

Phase 4

Completed

• Conditions: Bacterial Infections; Eye Infections
• Interventions: Drug: Moxifloxacin; Drug: Azithromycin

• Registration Number: NCT00564447
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-11-20
• Study First Submitted QC: 2007-11-27
• Study First Posted: 2007-11-28
• Study Start: 2007-12
• Primary Completion: 2007-12
• Results First Submitted: 2011-06-27
• Results First Submitted QC: 2011-06-27
• Results First Posted: 2011-07-26
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-20
• Last Update Posted: 2011-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Moxifloxacin-30 minutes post dose	Moxifloxacin	-
Moxifloxacin-12 hours post dose	Moxifloxacin	-
Azithromycin-24 hours post dose	Azithromycin	-
Moxifloxacin-2 hours post dose	Moxifloxacin	-
Azithromycin-2 hours post dose	Azithromycin	-
Moxafloxacin-24 hours post dose	Moxifloxacin	-
Azithromycin-30 minutes Post dose	Azithromycin	-
Azithromycin-12 hours post dose	Azithromycin	-

Primary Outcome Measures

Name	Time	Method
Assessment of Pharmacokinetic Parameters	Over 24 hours	Conjunctiva Concentration of Azithromycin and Moxifloxacin