NCT03004924

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

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 the Treatment of Bacterial Conjunctivitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 753 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Bacterial Conjunctivitis

Interventions

Type	Name	Description
DRUG	SHP640	Instill 1 drop of SHP640 (povidone-iodine \[PVPI\] 0.6% and Dexamethasone 0.1%) ophthalmic suspension in each eye QID (with a minimum of 2 hours between doses) for 7 days.
DRUG	PVP-I 0.6%	Instill 1 drop of PVP-I 0.6% ophthalmic solution in each eye 4 times QID (with a minimum of 2 hours between doses) for 7 days.
DRUG	Placebo	Instill 1 drop of placebo ophthalmic solution in each eye 4 times QID (with a minimum of 2 hours between doses) for 7 days.

Timeline

• Start date: 2017-03-29
• Primary completion: 2018-10-01
• Completion: 2018-10-01
• First posted: 2016-12-29
• Last updated: 2021-06-09
• Results posted: 2019-10-28

Locations

163 sites across 13 countries: United States, Australia, Austria, Canada, Estonia, France, Hungary, Israel, Italy, Poland, Puerto Rico, South Africa, Spain

Regulatory

• FDA-regulated drug study