drugset / Trial / NCT03004924

Treatment of Bacterial Conjunctivitis With SHP640 Compared to PVP-Iodine and Placebo

NCT03004924 ↗

Phase 3 Completed 753 enrolled Shire
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2017-03-29
Primary completion
2018-10-01
Completion
2018-10-01

Outcome

Missed primary endpoint

registry analysis (superiority test); SHP640 vs Placebo; p = 0.127; Difference in response rate 7.7 (95% CI -1.6 to 16.9); Fisher Exact NCT03004924 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule 0.1 % Other
Comparator Povidone-Iodine Other / unclassified 0.6 % Other