At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 263 enrolled
Drug / intervention
SUN-131 1.5% TDS +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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 Patients With a Chalazion (SUN-131-03)
In Brief
A Phase 3 clinical trial evaluating SUN-131 1.5% TDS and Placebo TDS for Chalazion. Completed, enrolled 263 participants across 65 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChalazion
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
Enrollment StartJul 2017
First PostedAug 2017
Primary CompletionAug 2018
TodayJul 2026
First PostedAug 14, 2017
Enrollment StartJul 31, 2017
Primary CompletionAug 17, 2018
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 8.9 years ago
Interventions
SUN-131 1.5% TDSdrug
SUN-131 1.5% TDS will be worn for 14 days
Placebo TDSdrug
No active substance; Placebo TDS will be worn each day for 14 days