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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
263
SUN-131 1.5% TDS will be worn for 14 days
No active substance; Placebo TDS will be worn each day for 14 days
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.
Time frame: Baseline to Day 15 ± 1
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.
Time frame: Baseline to Day 15 ± 1
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SUN-131-03 Investigational Site
Chandler, Arizona, United States
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
...and 55 more locations