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

September 20, 2011 updated by: Merck Sharp & Dohme LLC

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • AzaSite
EXPERIMENTAL: Azithromycin-2 hours post dose
Drug: Azithromycin
azithromycin topical solution 1% given as a single drop in a single eye
Other Names:
  • AzaSite
EXPERIMENTAL: Azithromycin-12 hours post dose
Drug: Azithromycin
azithromycin topical solution 1% given as a single drop in a single eye
Other Names:
  • AzaSite
EXPERIMENTAL: Azithromycin-24 hours post dose
Drug: Azithromycin
azithromycin topical solution 1% given as a single drop in a single eye
Other Names:
  • AzaSite
EXPERIMENTAL: Moxifloxacin-30 minutes post dose
Drug: Moxifloxacin
Moxifloxacin topical solution given as a single drop in a single eye
Other Names:
  • Vigamox
EXPERIMENTAL: Moxifloxacin-2 hours post dose
Drug: Moxifloxacin
Moxifloxacin topical solution given as a single drop in a single eye
Other Names:
  • Vigamox
EXPERIMENTAL: Moxifloxacin-12 hours post dose
Drug: Moxifloxacin
Moxifloxacin topical solution given as a single drop in a single eye
Other Names:
  • Vigamox
EXPERIMENTAL: Moxafloxacin-24 hours post dose
Drug: Moxifloxacin
Moxifloxacin topical solution given as a single drop in a single eye
Other Names:
  • Vigamox

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of Pharmacokinetic Parameters
Time Frame: Up to 24 hours
Up to 24 hours
Assessment of Pharmacokinetic Parameters
Time Frame: Over 24 hours
Conjunctiva Concentration of Azithromycin and Moxifloxacin
Over 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Reza Haque, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (ACTUAL)

December 1, 2007

Study Registration Dates

First Submitted

November 20, 2007

First Submitted That Met QC Criteria

November 27, 2007

First Posted (ESTIMATE)

November 28, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

September 22, 2011

Last Update Submitted That Met QC Criteria

September 20, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 041-102
  • P08654

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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