Status:
COMPLETED
Safety and Efficacy Study of SUN-131 Transdermal System (TDS) as Compared to Placebo TDS in Patients With a Chalazion
Lead Sponsor:
Senju USA, Inc.
Conditions:
Chalazion
Eligibility:
All Genders
6+ years
Phase:
PHASE3
Brief 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 s...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 31 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 17 2018
Estimated Enrollment :
263 Patients enrolled
Trial Details
Trial ID
NCT03248440
Start Date
July 31 2017
End Date
August 17 2018
Last Update
August 5 2021
Active Locations (65)
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1
SUN-131-03 Investigational Site
Chandler, Arizona, United States, 85225
2
SUN-131-03 Investigational Site
Prescott, Arizona, United States, 86301
3
SUN-131-03 Investigational Site
Sun City, Arizona, United States, 85351
4
SUN-131-03 Investigational Site
Glendale, California, United States, 91204