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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

November 20, 2007
September 20, 2011
December 2007
December 2007   (final data collection date for primary outcome measure)
  • 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
Assessment of pharmacokinetic parameters [ Time Frame: Up to 24 hours ]
Complete list of historical versions of study NCT00564447 on ClinicalTrials.gov Archive Site
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Study of AzaSite (Azithromycin) Versus Vigamox in the Conjunctiva of Healthy Volunteers
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

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
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Bacterial Infections
  • Eye Infections
  • 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
  • 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
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
Not Provided
December 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00564447
041-102, P08654
Not Provided
Saiid Davari, Inspire Pharmaceuticals, Inc.
Merck
Not Provided
Study Director: Reza Haque Merck
Merck
September 2011

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