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

Completed · Phase 3 · Has a placebo group

Conditions studied: Chalazion

In brief

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.

Key facts

Study ID

NCT03248440

Run by

Senju USA, Inc.

People needed

263

Starts

2017-07-31

Expected to finish

2018-08-17

Last updated by the study team

2021-08-05

Who can join

Age: 6 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• SUN-131-03 Investigational Site — Prescott, Arizona, United States
• SUN-131-03 Investigational Site — Sun City, Arizona, United States
• SUN-131-03 Investigational Site — Glendale, California, United States
• SUN-131-03 Investigational Site — Lancaster, California, United States
• SUN-131-03 Investigational Site — Long Beach, California, United States
• SUN-131-03 Investigational Site — Los Angeles, California, United States
• SUN-131-03 Investigational Site — Mission Hills, California, United States
• SUN-131-03 Investigational Site — Petaluma, California, United States
• SUN-131-03 Investigational Site — Rancho Cordova, California, United States
• SUN-131-03 Investigational Site — San Diego, California, United States
• SUN-131-03 Investigational Site — Santa Ana, California, United States
• SUN-131-03 Investigational Site — Colorado Springs, Colorado, United States
• SUN-131-03 Investigational Site — Littleton, Colorado, United States
• SUN-131-03 Investigational Site — Fort Myers, Florida, United States
• SUN-131-03 Investigational Site — Largo, Florida, United States
• SUN-131-03 Investigational Site — Maitland, Florida, United States
• SUN-131-03 Investigational Site — Tamarac, Florida, United States
• SUN-131-03 Investigational Site — Albany, Georgia, United States
• SUN-131-03 Investigational Site — Morrow, Georgia, United States
• SUN-131-03 Investigational Site — Roswell, Georgia, United States
• SUN-131-03 Investigational Site — Chicago Ridge, Illinois, United States
• SUN-131-03 Investigational Site — Glenview, Illinois, United States
• SUN-131-03 Investigational Site — Hoffman Estates, Illinois, United States
• SUN-131-03 Investigational Site — Lake Villa, Illinois, United States
• SUN-131-03 Investigational Site — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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