Trials / Completed
CompletedNCT03248440
Safety and Efficacy Study of SUN-131 Transdermal System (TDS) as Compared to Placebo TDS in Patients With a Chalazion
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)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 263 (actual)
- Sponsor
- Senju USA, Inc. · Industry
- Sex
- All
- Age
- 6 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SUN-131 1.5% TDS | SUN-131 1.5% TDS will be worn for 14 days |
| DRUG | Placebo TDS | No active substance; Placebo TDS will be worn each day for 14 days |
Timeline
- Start date
- 2017-07-31
- Primary completion
- 2018-08-17
- Completion
- 2018-08-17
- First posted
- 2017-08-14
- Last updated
- 2021-08-05
- Results posted
- 2021-08-05
Locations
65 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03248440. Inclusion in this directory is not an endorsement.