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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00564447
Recruitment Status : Completed
First Posted : November 28, 2007
Results First Posted : July 26, 2011
Last Update Posted : September 22, 2011
Sponsor:
Information provided by:
Merck Sharp & Dohme LLC

Study Description
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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

Condition or disease Intervention/treatment Phase
Bacterial Infections Eye Infections Drug: Azithromycin Drug: Moxifloxacin Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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 Start Date : December 2007
Actual Primary Completion Date : December 2007

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Azithromycin-30 minutes Post dose Drug: Azithromycin
azithromycin topical solution 1% given as a single drop in a single eye
Other Name: AzaSite
Experimental: Azithromycin-2 hours post dose Drug: Azithromycin
azithromycin topical solution 1% given as a single drop in a single eye
Other Name: AzaSite
Experimental: Azithromycin-12 hours post dose Drug: Azithromycin
azithromycin topical solution 1% given as a single drop in a single eye
Other Name: AzaSite
Experimental: Azithromycin-24 hours post dose Drug: Azithromycin
azithromycin topical solution 1% given as a single drop in a single eye
Other Name: AzaSite
Experimental: Moxifloxacin-30 minutes post dose Drug: Moxifloxacin
Moxifloxacin topical solution given as a single drop in a single eye
Other Name: Vigamox
Experimental: Moxifloxacin-2 hours post dose Drug: Moxifloxacin
Moxifloxacin topical solution given as a single drop in a single eye
Other Name: Vigamox
Experimental: Moxifloxacin-12 hours post dose Drug: Moxifloxacin
Moxifloxacin topical solution given as a single drop in a single eye
Other Name: Vigamox
Experimental: Moxafloxacin-24 hours post dose Drug: Moxifloxacin
Moxifloxacin topical solution given as a single drop in a single eye
Other Name: Vigamox


Outcome Measures
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Primary Outcome Measures :
  1. Assessment of Pharmacokinetic Parameters [ Time Frame: Up to 24 hours ]
  2. Assessment of Pharmacokinetic Parameters [ Time Frame: Over 24 hours ]
    Conjunctiva Concentration of Azithromycin and Moxifloxacin


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00564447


Sponsors and Collaborators
Merck Sharp & Dohme LLC
Investigators
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Study Director: Reza Haque Merck Sharp & Dohme LLC
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Saiid Davari, Inspire Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00564447    
Other Study ID Numbers: 041-102
P08654
First Posted: November 28, 2007    Key Record Dates
Results First Posted: July 26, 2011
Last Update Posted: September 22, 2011
Last Verified: September 2011
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Bacterial Infections
Eye Infections
Disease Attributes
Pathologic Processes
Bacterial Infections and Mycoses
Eye Diseases
Azithromycin
 Moxifloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents