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 chalazion based on the proportion of subjects that have complete response. Complete response is defined as the absence of any significant clinical signs of a chalazion with possible scaring or skin defects resulting from healing of the chalazion allowed.
Subjects will be randomly assigned to receive one of the following treatments in the affected eyelid: * SUN-131 1.5% TDS (n=30) * Placebo TDS (n=30) At baseline prior to application of the TDS an assessment will be performed on both the subject's eyes including the chalazion site itself. All subjects will return to the site on Days 8±1, 15±2 and 23±2 for evaluations. During the the 23±2 visit, a clinical evaluation will be performed to determine if the chalazion is still present. There will also be follow up on Day 29±3, and on Day 50 visit (study days 47 to 60) to evaluate the safety and durability of the effect of the SUN-131 1.5% TDS. Data review and safety assessments will be conducted by the medical monitor periodically throughout the trial and at the conclusion of the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
Active transdermal patch
Placebo transdermal patch for blinding
WCCT Global Ophthalmology Research
Santa Ana, California, United States
Corneal Consultants of Colorado, P.C.
Littleton, Colorado, United States
George Washington University Medical Faculty Association
Washington D.C., District of Columbia, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Complete Response
Complete response is defined as the absence of any significant clinical signs of a chalazion with possible scaring or skin defects resulting from healing of the chalazion allowed.
Time frame: Day 23±2
Change in Chalazion Size
Size of the chalazion will be assessed using a caliper and measured as height and width in mm.
Time frame: Study days 47 to 60
Change in Chalazion Erythema
Erythema of the chalazion site itself will be assessed using a 5-point scale (i.e. 0 = no signs of erythema; to 4 = severe erythema)
Time frame: Study days 47 to 60
Pain Associated with the Chalazion
Pain assessments will be done at the clinical site using a 100 mm visual analog scale.
Time frame: Study days 47 to 60
Time to Complete Response of the Target Chalazion
Time frame: Study days 47 to 60
Durability of Response
Clinical assessment of the presence of a chalazion if there was a complete response by Day 23±2.
Time frame: Study days 47 to 60
Comparison of Adverse Event Rates and Skin Irritation between Treatment Arms
Time frame: Day 23±2
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Cornerstone Eye Care
High Point, North Carolina, United States
Virginia Eye Consultants
Norfolk, Virginia, United States