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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: Completed Phase 3 study of Bacterial Conjunctivitis, sponsored by Merck Sharp & Dohme.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Clinical resolution is defined as absence of all three clinical signs (ocular discharge, bulbar conjunctival injection, and palpebral conjunctival injection).
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
| Field | Value |
|---|---|
| Enrollment Target | 743 participants |
| Start Date | 2004-07 |
| Est. Completion | 2005-10 |
| Phase | Phase 3 |
What the finished NCT00105469 record still lists
NCT00105469 is an interventional study that assigns participants to a tested intervention. The registered 743 participants enrollment target is mid-sized for trials with a published cap, above the 519-participant average among 7 other Bacterial Conjunctivitis trials with a reported enrollment target (43% higher).
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 names 20 study sites across 12 states, led by 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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