Study of AzaSite Versus Vigamox in the Tears 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 Tears of Healthy Volunteers Following a Single Ocular Administration

The purpose of this study is to evaluate the drug concentrations of AzaSite compared to Vigamox in tears of healthy volunteers

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai School of Medicine

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 visual acuity, using corrective lenses (no contact lenses) if necessary, in both eyes of at least +0.7 as assessed by Early Treatment of Diabetic Retinopathy Study.
  • Have normal lid anatomy.

Exclusion Criteria:

  • Have an abnormal biomicroscopy or ophthalmoscopy exam.
  • Have a diagnosis of dry eye disease or have experienced any of the dry eye symptoms (photophobia, foreign body sensation, itching, burning, pain, dry or grittiness) in the past thirty days.
  • Have used artificial tears in the past thirty days.
  • Have a diagnosis of on-going ocular infection or lid margin inflammation.
  • Have ever had penetrating ocular surface or intraocular surgery.
  • Have a known hypersensitivity to azithromycin, or any macrolide antibiotic or to any of the ingredients in AzaSite.
  • Have had a known hypersensitivity to Vigamox or any fluoroquinolone antibiotics or to any of the ingredients in Vigamox.
  • Have had corneal or lid abnormalities.
  • Have glaucoma, or Intra Ocular Pressure of 22 mm Hg or greater in one or both eyes.
  • Have any ocular pathology with the exception of cataracts.
  • Have a serious systemic disease or uncontrolled medical condition.
  • Have experienced symptoms of viral or allergic conjunctivitis in the past 30 days.
  • Have a history of liver or kidney disease resulting in persisting dysfunction.

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
ACTIVE_COMPARATOR: AzaSite
Drug: AzaSite (azithromycin ophthalmic solution)
One drop ophthalmic solution at Visit 2
ACTIVE_COMPARATOR: Vigamox
Drug: Vigamox (moxifloxacin hydrochloride ophthalmic solution)
One drop ophthalmic solution at Visit 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Concentration of AzaSite and Vigamox in the Tear Fluid Across Six Time Points Ranging From 15 Minutes to 24 Hours Following Administration.
Time Frame: 15 minutes, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours
15 minutes, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours

Collaborators and Investigators

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

Sponsor

Merck Sharp & Dohme LLC

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

March 1, 2008

Primary Completion (ACTUAL)

October 1, 2008

Study Registration Dates

First Submitted

December 14, 2007

First Submitted That Met QC Criteria

December 14, 2007

First Posted (ESTIMATE)

December 18, 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

  • 041-101
  • P08653

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.

Clinical Trials on Bacterial Infections

Clinical Trials on AzaSite (azithromycin ophthalmic solution)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belarus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe