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COMPLETED Phase 3

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

NCT00105469 · View on ClinicalTrials.gov ↗

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

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

741 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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 743 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 741 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00105469 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Florida, Missouri, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00105469?

The interventions under investigation include: AzaSite (DRUG), Tobramycin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00105469?

This trial is sponsored by Merck Sharp & Dohme, which has 741 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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