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

Senju Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Chalazion

Treatments: Drug: Placebo TDS; Drug: SUN-131 1.5% TDS

Study type: Interventional

Funder types: Industry

Identifiers

NCT03248440

SUN-131-03

Details and patient eligibility

About

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.

Enrollment: 263 patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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263 participants in 2 patient groups, including a placebo group

SUN-131 1.5% TDS

Experimental group

Treatment:

Drug: SUN-131 1.5% TDS

Placebo TDS

Placebo Comparator group

Treatment:

Drug: Placebo TDS