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OpenTrials
Completed

NCT Number: NCT00564447

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

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

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Key information

Conditions

Bacterial Infections Bacterial Infections and Mycoses Eye Diseases Eye Infections Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Azithromycin

Drug

azithromycin topical solution 1% given as a single drop in a single eye

Other names: AzaSite

moxifloxacin

Drug

Moxifloxacin topical solution given as a single drop in a single eye

Other names: Vigamox

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2007
First posted
Nov 28, 2007
Registry last updated
Sep 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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