Safety and Efficacy Study of SUN-131 Transdermal System (TDS) as Compared to Placebo TDS in Patie… (NCT03248440) | Clinical Trial Compass
CompletedPhase 3
Safety and Efficacy Study of SUN-131 Transdermal System (TDS) as Compared to Placebo TDS in Patients With a Chalazion
United States263 participantsStarted 2017-07-31
Plain-language 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.
Who can participate
Age range6 Years
SexALL
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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.
What they're measuring
1
The Proportions of Participants Who Experienced Complete Response of the Study Chalazion by Day 15 ± 1