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NCT00105469 · ClinicalTrials.gov registry record · Phase 3

Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Tobramycin for Bacterial Conjunctivitis (C-01-401-004)

A Phase 3 study of Bacterial Conjunctivitis, sponsored by Merck Sharp & Dohme.

Completed
Registry status
Phase 3
Development phase
743
Enrollment target
20
Study locations

NCT00105469 is a Phase 3 study of Bacterial Conjunctivitis that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 743 participants, above the 519-participant average among 7 other Bacterial Conjunctivitis trials with a reported enrollment target (43% higher). The trial reports 20 study locations across 12 states.

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The verdict

NCT00105469, a Phase 3 study of Bacterial Conjunctivitis, has completed, sponsored by Merck Sharp & Dohme.

COMPLETED
Registry status
Phase 3
Development phase
743 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to evaluate the clinical and microbial efficacy and safety of AzaSite compared to tobramycin for bacterial conjunctivitis. Adults and children one year of age and older with bacterial conjunctivitis in at least one eye are eligible. Subjects will be randomly assigned to the AzaSite group or Tobramycin group. Three visits will be required for the study.

Conditions Studied

Bacterial Conjunctivitis

Interventions

  • DRUG AzaSite
  • DRUG Tobramycin

Study Locations (20)

Florida

  • Palm Beach Eye Associates - Atlantis
  • The Eye Associates - Bradenton
  • Alan Shuster, MD - Jupiter
  • Pasco Eye Institute - New Port Richey
  • Tukoi Institute for Clinical Research - North Miami Beach
  • Advanced Eye Care - Panama City
  • Presidential Eye Center - West Palm Beach

Missouri

  • Mason Eye Institute - Columbia
  • Ophthalmology Associates - Creve Coeur
  • Research Eye Care Center - Kansas City

Alabama

  • Renaissance Center - Birmingham

Colorado

  • Children's Eye Physicians - Littleton

Idaho

  • Jon Fishburn, MD - Boise

Indiana

  • Medisphere Medical Research Center, LLC - Evansville

Kansas

  • Hutchinson Clinic - Hutchinson

Massachusetts

  • Massachusetts Eye and Ear Infirmary - Boston

Trial Details

FieldValue
Enrollment Target 743 participants
Start Date 2004-07
Est. Completion 2005-10
Phase Phase 3

Sponsor

Merck Sharp & Dohme

558 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00105469

The ClinicalTrials.gov registry entry for NCT00105469 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 743 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 519-participant average among 7 other Bacterial Conjunctivitis trials with a reported enrollment target (43% higher). The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Bacterial Conjunctivitis appearing as the primary indexed condition, and to 2 interventions - of which AzaSite is the first listed.

NCT00105469 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Florida, Missouri, Alabama.

Frequently Asked Questions

What is clinical trial NCT00105469 about?

NCT00105469 is a clinical study titled "Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Tobramycin for Bacterial Conjunctivitis (C-01-401-004)". The purpose of this study is to evaluate the clinical and microbial efficacy and safety of AzaSite compared to tobramycin for bacterial conjunctivitis. Adults and children one year of age and older with bacterial conjunctivitis in at least one eye are eligible. Subjects will be randomly assigned to ...

What is the current status of trial NCT00105469?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 743 participants. The study started on 2004-07. Estimated completion is 2005-10.

What conditions does trial NCT00105469 study?

This clinical trial studies the following conditions: Bacterial Conjunctivitis.

What interventions are being tested in trial NCT00105469?

The interventions under investigation include: AzaSite (DRUG), Tobramycin (DRUG).

Who is sponsoring clinical trial NCT00105469?

This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00105469 being conducted?

This trial has 20 study locations across Alabama, Colorado, Florida, Idaho, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.