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

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00564447
First received: November 20, 2007
Last updated: September 20, 2011
Last verified: September 2011
History of Changes
  Purpose

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 Intervention Phase
Bacterial Infections
Eye Infections
 Drug: Azithromycin
Drug: Moxifloxacin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Assessment of Pharmacokinetic Parameters [ Time Frame: Up to 24 hours ] [ Designated as safety issue: No ]
  • Assessment of Pharmacokinetic Parameters [ Time Frame: Over 24 hours ] [ Designated as safety issue: No ]
    Conjunctiva Concentration of Azithromycin and Moxifloxacin


Enrollment: 48
Study Start Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00564447

Sponsors and Collaborators
Merck
Investigators
Study Director: Reza Haque Merck
  More Information

No publications provided by Merck

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Saiid Davari, Inspire Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00564447     History of Changes
Other Study ID Numbers: 041-102, P08654
Study First Received: November 20, 2007
Results First Received: June 27, 2011
Last Updated: September 20, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Bacterial Infections
Eye Infections
Infection
Eye Diseases
Azithromycin
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
 Therapeutic Uses
Pharmacologic Actions
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013