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

• Status: Completed
• Trial end date: 2018-08-17
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Senju USA, Inc.

Criteria

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.