Phase 3
N=263
Safety and Efficacy Study of SUN-131 Transdermal System (TDS) as Compared to Placebo TDS in Patients With a Chalazion
Chalazion
Bottom Line
View on ClinicalTrials.gov: NCT03248440 ↗Enrolled (actual)
263
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcome: Primary: The Proportions of Participants Who Experienced Complete Response of the Study Chalazion by Day 15 ± 1 — 28; 32 Participants — p=0.579
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- SUN-131 1.5% TDS (Drug); Placebo TDS (Drug)
- Age
- Pediatric, Adult, Older Adult · 6+ yrs
- Sex
- All
- Sponsor
- Senju USA, Inc.
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Proportions of Participants Who Experienced Complete Response of the Study Chalazion by Day 15 ± 1 |
28; 32 | 0.579 |
| SECONDARY The Proportions of Participants Who Experienced Complete Response of the Study Chalazion With Upper Eyelid by Day 15 ± 1 |
14; 27 | 0.082 |
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.
Eligibility Criteria
Inclusion Criteria
- Subjects aged ≥ 6 years of either sex and of any race
- Subjects with a diagnosis of a single chalazion
- Subjects with chalazion erythema score of ≥ 1
- Normal eyelid function without active signs of eye and eyelid infection in either eye.
- Must be willing and able to correctly apply and wear a transdermal patch to the eyelid
- Avoid wearing contact lenses in the study eye
Exclusion Criteria
- Chalazion that has atypical features (a recurring chalazion at the same spot, abnormal surrounding lid tissue, associated loss of tissues).
- History of chalazion incision and curettage in study eyelid.
- Multiple chalazia in any one eyelid.
- Active ocular or eyelid infection Presence of hordeolum in any one eyelid.
- An abnormal skin condition on the study eyelid region (e.g., eczema, psoriasis, atopic dermatitis, etc.) where the study drug will be applied.
- Diagnosed with glaucoma in either eye.
- History of steroid-induced elevation of IOP.
- Female subjects who are pregnant or lactating.
Data sourced from ClinicalTrials.gov (NCT03248440). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.