Safety and Efficacy Study of SUN 131 TDS as Compared to Placebo TDS in Adult Patients With a Chalazion

Chalazion Clinical Trial

Official title: A Multi-Center, Double-Masked, Randomized, Placebo-Controlled Evaluation of the Safety and Efficacy of SUN 131 Transdermal System (TDS) as Compared to Placebo TDS in Adult Patients With a Chalazion

Status Completed

Clinical Trial Summary

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 chalazion based on the proportion of subjects that have complete response. Complete response is defined as the absence of any significant clinical signs of a chalazion with possible scaring or skin defects resulting from healing of the chalazion allowed.

Clinical Trial Description

Subjects will be randomly assigned to receive one of the following treatments in the affected eyelid:

• SUN-131 1.5% TDS (n=30)

• Placebo TDS (n=30)

At baseline prior to application of the TDS an assessment will be performed on both the subject's eyes including the chalazion site itself.

All subjects will return to the site on Days 8±1, 15±2 and 23±2 for evaluations. During the the 23±2 visit, a clinical evaluation will be performed to determine if the chalazion is still present.

There will also be follow up on Day 29±3, and on Day 50 visit (study days 47 to 60) to evaluate the safety and durability of the effect of the SUN-131 1.5% TDS.

Data review and safety assessments will be conducted by the medical monitor periodically throughout the trial and at the conclusion of the study. ;

Related Conditions & MeSH terms

• Chalazion

• NCT number: NCT02338648
• Study type: Interventional
• Source: Senju USA, Inc.
• Status: Completed
• Phase: Phase 2
• Start date: October 2014
• Completion date: January 2016