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NCT03004924 · ClinicalTrials.gov registry record · Phase 3
Treatment of Bacterial Conjunctivitis With SHP640 Compared to PVP-Iodine and Placebo
A Phase 3 study of Bacterial Conjunctivitis, sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 753
- Enrollment target
- 20
- Study locations
NCT03004924: Completed Phase 3 study of Bacterial Conjunctivitis, sponsored by Shire.
NCT03004924 is a Phase 3 study of Bacterial Conjunctivitis that has completed, run by Shire. The registered enrollment target is 753 participants, above the 517-participant average among 7 other Bacterial Conjunctivitis trials with a reported enrollment target (46% higher). The trial reports 20 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03004924, a Phase 3 study of Bacterial Conjunctivitis, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 753 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to determine if an investigational treatment is effective compared with placebo and PVP-Iodine in the treatment of adults and children with bacterial conjunctivitis.
Primary Outcome
Clinical resolution was defined as absence (score=0) of bulbar conjunctival injection and ocular conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from validated bulbar redness (VBR) scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent d
Conditions Studied
Interventions
- DRUG Placebo
- DRUG SHP640
- DRUG PVP-I 0.6%
Study Locations (20)
California
- Milton M. Hom, OD, FAAO - Azusa
- Clark S Tsai Eye Center - Concord
- Lugene Eye Institute Inc - Glendale
- Mark B. Kislinger, MD, Inc. - Glendora
- Inland Eye Specialists - Hemet
- Lakeside Vision Center - Irvine
- Hull Eye Center - Lancaster
- Eye Physicians of Long Beach - Long Beach
- Oxford Optical - Los Angeles
- Sok H. Nam, M.D. Inc. - Los Angeles
- University of Southern California - Los Angeles
- Macy Eye Center - Los Angeles
- North Valley Eye Medical Group Inc - Mission Hills
- North Bay Eye Associates, Inc. - Petaluma
- Arch Health Partners - Poway
Arizona
- Arizona Eye Center - Chandler
- Cornea and Cataract Consultants of Arizona - Phoenix
- M&M Eye Institute - Prescott
- Schwartz Laser Eye Center - Scottsdale
- Walman Eye Center - Sun City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 753 participants |
| Start Date | 2017-03-29 |
| Est. Completion | 2018-10-01 |
| Phase | Phase 3 |
What the finished NCT03004924 record still lists
NCT03004924 is an interventional study that assigns participants to a tested intervention. The registered 753 participants enrollment target is mid-sized for trials with a published cap, above the 517-participant average among 7 other Bacterial Conjunctivitis trials with a reported enrollment target (46% higher).
The record links to 1 condition, with Bacterial Conjunctivitis appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT03004924 names 20 study sites across 2 states, led by California, Arizona.
Frequently Asked Questions
What is clinical trial NCT03004924 about?
NCT03004924 is a clinical study titled "Treatment of Bacterial Conjunctivitis With SHP640 Compared to PVP-Iodine and Placebo". The purpose of this study is to determine if an investigational treatment is effective compared with placebo and PVP-Iodine in the treatment of adults and children with bacterial conjunctivitis.
What is the current status of trial NCT03004924?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 753 participants. The study started on 2017-03-29. Estimated completion is 2018-10-01.
What conditions does trial NCT03004924 study?
This clinical trial studies the following conditions: Bacterial Conjunctivitis.
What interventions are being tested in trial NCT03004924?
The interventions under investigation include: Placebo (DRUG), SHP640 (DRUG), PVP-I 0.6% (DRUG).
Who is sponsoring clinical trial NCT03004924?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03004924 being conducted?
This trial has 20 study locations across Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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