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NCT00105534 · ClinicalTrials.gov registry record · Phase 3
Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Vehicle for Bacterial Conjunctivitis (C-01-401-003)
A Phase 3 study of Bacterial Conjunctivitis, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 3
- Development phase
- 685
- Enrollment target
- 20
- Study locations
NCT00105534: Completed Phase 3 study of Bacterial Conjunctivitis, sponsored by Merck Sharp & Dohme.
NCT00105534 is a Phase 3 study of Bacterial Conjunctivitis that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 685 participants, above the 527-participant average among 7 other Bacterial Conjunctivitis trials with a reported enrollment target (30% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00105534, a Phase 3 study of Bacterial Conjunctivitis, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 685 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 vehicle for bacterial conjunctivitis. Adults and children one year of age and older with bacterial conjunctivitis in at least one eye may be eligible. Subjects will be randomly assigned to receive either 1.0 % AzaSite or Vehicle. Three visits will be required for this 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
- OTHER Vehicle
- DRUG AzaSite
Study Locations (20)
California
- Rx For Life, Inc. - Cudahy
- North Bay Eye Associates - Petaluma and Santa Rosa
- San Diego Eye and Laser Center - San Diego
Louisiana
- Bossier Optical Inc. - Bossier City
- Bohn and Joseph Eye Center - Lafayette
- The Louisiana Eye Center - Zachary
North Carolina
- Charlotte Eye, Ear, Nose, and Throat - Charlotte
- Horizon Eye Center - Charlotte
- Groat Eyecare Associates - Greensboro
New Jersey
- Clinical Research Laboratories - Piscataway
- Advanced Eyecare and Laser Center - Runnemede
Arizona
- I Care! Eye Care! - Flagstaff
Colorado
- Western States Clinical Research - Wheat Ridge
Connecticut
- Opticare Eye Health Center - Waterbury
Florida
- International Eye Center - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 685 participants |
| Start Date | 2004-07 |
| Est. Completion | 2006-01 |
| Phase | Phase 3 |
What the finished NCT00105534 record still lists
NCT00105534 is an interventional study that assigns participants to a tested intervention. The registered 685 participants enrollment target is mid-sized for trials with a published cap, above the 527-participant average among 7 other Bacterial Conjunctivitis trials with a reported enrollment target (30% higher).
The record links to 1 condition, with Bacterial Conjunctivitis appearing as the primary indexed condition, and to 2 interventions - of which Vehicle is the first listed.
NCT00105534 names 20 study sites across 13 states, led by California, Louisiana, North Carolina.
Frequently Asked Questions
What is clinical trial NCT00105534 about?
NCT00105534 is a clinical study titled "Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Vehicle for Bacterial Conjunctivitis (C-01-401-003)". The purpose of this study is to evaluate the clinical and microbial efficacy and safety of AzaSite compared to vehicle for bacterial conjunctivitis. Adults and children one year of age and older with bacterial conjunctivitis in at least one eye may be eligible. Subjects will be randomly assigned to ...
What is the current status of trial NCT00105534?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 685 participants. The study started on 2004-07. Estimated completion is 2006-01.
What conditions does trial NCT00105534 study?
This clinical trial studies the following conditions: Bacterial Conjunctivitis.
What interventions are being tested in trial NCT00105534?
The interventions under investigation include: Vehicle (OTHER), AzaSite (DRUG).
Who is sponsoring clinical trial NCT00105534?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00105534 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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