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

Phase 3

Completed

• Conditions: Chalazion
• Interventions: Drug: Placebo TDS; Drug: SUN-131 1.5% TDS

• Registration Number: NCT03248440
• Lead Sponsor: Senju USA, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-31
• Study First Submitted: 2017-08-09
• Study First Submitted QC: 2017-08-09
• Study First Posted: 2017-08-14
• Primary Completion: 2018-08-17
• Study Completion: 2018-08-17
• Disposition First Submitted: 2020-09-17
• Results First Submitted: 2021-07-07
• Status Verified: 2021-08
• Results First Submitted QC: 2021-08-03
• Disposition First Submitted QC: 2021-08-03
• Last Update Submitted: 2021-08-03
• Results First Posted: 2021-08-05
• Disposition First Posted: 2021-08-05
• Last Update Posted: 2021-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 263

Inclusion Criteria

1. Subjects aged ≥ 6 years of either sex and of any race
2. Subjects with a diagnosis of a single chalazion
3. Subjects with chalazion erythema score of ≥ 1
4. Normal eyelid function without active signs of eye and eyelid infection in either eye.
5. Must be willing and able to correctly apply and wear a transdermal patch to the eyelid
6. Avoid wearing contact lenses in the study eye

Exclusion Criteria

1. Chalazion that has atypical features (a recurring chalazion at the same spot, abnormal surrounding lid tissue, associated loss of tissues).
2. History of chalazion incision and curettage in study eyelid.
3. Multiple chalazia in any one eyelid.
4. Active ocular or eyelid infection Presence of hordeolum in any one eyelid.
5. An abnormal skin condition on the study eyelid region (e.g., eczema, psoriasis, atopic dermatitis, etc.) where the study drug will be applied.
6. Diagnosed with glaucoma in either eye.
7. History of steroid-induced elevation of IOP.
8. Female subjects who are pregnant or lactating.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo TDS	Placebo TDS	-
SUN-131 1.5% TDS	SUN-131 1.5% TDS	-

Primary Outcome Measures

Name	Time	Method
The Proportions of Participants Who Experienced Complete Response of the Study Chalazion by Day 15 ± 1	Baseline to Day 15 ± 1	Complete response was defined as the absence of any significant clinical signs of a chalazion, based on clinical judgment by an investigator.

Secondary Outcome Measures

Name	Time	Method
The Proportions of Participants Who Experienced Complete Response of the Study Chalazion With Upper Eyelid by Day 15 ± 1	Baseline to Day 15 ± 1	Complete response was defined as the absence of any significant clinical signs of a chalazion, based on clinical judgment by an investigator.

Trial Locations

Locations (1)

SUN-131-03 Investigational Site; 🇺🇸 Racine, Wisconsin, United States