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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Chalazion

Intervention / Treatment
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* Drug: SUN-131 1.5% TDS
* Drug: Placebo TDS


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SUN-131 1.5% TDS<br> | Drug: SUN-131 1.5% TDS<br>* SUN-131 1.5% TDS will be worn for 14 days<br>|
| Placebo Comparator: Placebo TDS<br> | Drug: Placebo TDS<br>* No active substance; Placebo TDS will be worn each day for 14 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Proportions of Participants Who Experienced Complete Response of the Study Chalazion by 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. | Baseline to Day 15 ± 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Proportions of Participants Who Experienced Complete Response of the Study Chalazion With Upper Eyelid by 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. | Baseline to Day 15 ± 1 |