Clinical Trial: Treatment of Bacterial Conjunctivitis With SHP640 Compared to PVP-Iodine and Placebo
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Phase 3, Multi-center, Randomized, Double-Masked Study to Evaluate the Clinical Efficacy and Safety of SHP640 (PVP-Iodine 0.6% and Dexamethasone 0.1%) Ophthalmic Suspension Compared to Placebo in th
Brief 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.
Detailed Summary:
Sponsor: Shire
Current Primary Outcome: Clinical Resolution status between SHP640 and placebo as Measured by absence of Bulbar Conjunctival Injection and ocular conjunctival discharge [ Time Frame: Day 5 ]
Original Primary Outcome:
- Efficacy of SHP640 and Placebo on clinical resolution as measured by bulbar conjunctival injection [ Time Frame: Day 5 ]
- Efficacy of SHP640 and Placebo on clinical resolution as measured by watery conjunctival discharge [ Time Frame: Day 5 ]
Current Secondary Outcome: Bacterial Eradication Status between SHP640 and Placebo as Measured by Absence of All Bacterial Species Present at or Above Pathological Threshold at Baseline [ Time Frame: Day 5 ]
Original Secondary Outcome: Bacterial Eradication Status of SHP640 and Placebo as measured by absence of all bacterial species [ Time Frame: Day 5 ]
Information By: Shire
Dates:
Date Received: December 19, 2016
Date Started: March 29, 2017
Date Completion: March 1, 2018
Last Updated: April 24, 2017
Last Verified: April 2017