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 ]

Clinical resolution of bacterial conjunctivitis is defined as the absence (score=0) of bulbar conjunctival injection and ocular conjunctival discharge in the study eye. The study eye is defined based on subject's bulbar conjunctival redness and ocular conjunctival discharge scores at baseline as well as his/her bacterial culture results at baseline. Bulbar conjunctival injection will be assessed based on a 0-4 scale which uses pictures from the validated bulbar redness (VBR) scale. Watery conjunctival discharge will be assessed based on a 0-3 scale.


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 ]

Bacterial eradication status of the study eye is defined as absence of all bacterial species present at or above pathological threshold at baseline in the study eye at Day 5. The study eye is defined based on subject's bulbar conjunctival redness and ocular conjunctival discharge scores at baseline as well as his/her bacterial culture results at baseline.


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