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

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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 Corp.

Tracking Information
First Submitted Date  ICMJE November 20, 2007
First Posted Date  ICMJE November 28, 2007
Results First Submitted Date  ICMJE June 27, 2011
Results First Posted Date  ICMJE July 26, 2011
Last Update Posted Date September 22, 2011
Study Start Date  ICMJE December 2007
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2011)
  • Assessment of Pharmacokinetic Parameters [ Time Frame: Up to 24 hours ]
  • Assessment of Pharmacokinetic Parameters [ Time Frame: Over 24 hours ]
    Conjunctiva Concentration of Azithromycin and Moxifloxacin
Original Primary Outcome Measures  ICMJE
 (submitted: November 27, 2007)
Assessment of Pharmacokinetic Parameters [ Time Frame: Up to 24 hours ]
Change History Complete list of historical versions of study NCT00564447 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of AzaSite (Azithromycin) Versus Vigamox in the Conjunctiva of Healthy Volunteers
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Bacterial Infections
  • Eye Infections
Intervention  ICMJE
  • Drug: Azithromycin
    azithromycin topical solution 1% given as a single drop in a single eye
    Other Name: AzaSite
  • Drug: Moxifloxacin
    Moxifloxacin topical solution given as a single drop in a single eye
    Other Name: Vigamox
Study Arms  ICMJE
  • Experimental: Azithromycin-30 minutes Post dose
    Intervention: Drug: Azithromycin
  • Experimental: Azithromycin-2 hours post dose
    Intervention: Drug: Azithromycin
  • Experimental: Azithromycin-12 hours post dose
    Intervention: Drug: Azithromycin
  • Experimental: Azithromycin-24 hours post dose
    Intervention: Drug: Azithromycin
  • Experimental: Moxifloxacin-30 minutes post dose
    Intervention: Drug: Moxifloxacin
  • Experimental: Moxifloxacin-2 hours post dose
    Intervention: Drug: Moxifloxacin
  • Experimental: Moxifloxacin-12 hours post dose
    Intervention: Drug: Moxifloxacin
  • Experimental: Moxafloxacin-24 hours post dose
    Intervention: Drug: Moxifloxacin
Publications * Torkildsen G, O'Brien TP. Conjunctival tissue pharmacokinetic properties of topical azithromycin 1% and moxifloxacin 0.5% ophthalmic solutions: a single-dose, randomized, open-label, active-controlled trial in healthy adult volunteers. Clin Ther. 2008 Nov;30(11):2005-14. doi: 10.1016/j.clinthera.2008.10.020.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 27, 2007)
48
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00564447
Other Study ID Numbers  ICMJE 041-102
P08654
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Saiid Davari, Inspire Pharmaceuticals, Inc.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Reza Haque Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP