Safety and Efficacy Study of SUN-131 Transdermal System (TDS) as Compared to Placebo TDS in Patients With a Chalazion

Summary

This protocol for SUN-131 1.5% TDS is developed for the treatment of chalazion. SUN-131 1.5% TDS is designed for local delivery of a corticosteroid, to the upper or lower eyelid. The purpose of this study is to evaluate the efficacy and safety of SUN-131 1.5% TDS as compared with placebo TDS in the treatment of a chalazion.

Timeline

Start

2017-07-31

Primary completion

2018-08-17

Completion

2018-08-17

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo TDS vs SUN-131 1.5% TDS; p = 0.579; 2-sided Pearson's chi-square NCT03248440 ↗

Drugs

Indications