Clinical Trial: Safety and Efficacy Study of SUN 131 TDS as Compared to Placebo TDS in Adult Patients With a Chalazion

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Multi-Center, Double-Masked, Randomized, Placebo-Controlled Evaluation of the Safety and Efficacy of SUN 131 Transdermal System (TDS) as Compared to Placebo TDS in Adult Patients With a

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Senju USA, Inc.

Current Primary Outcome: Complete Response [ Time Frame: Day 23±2 ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in Chalazion Size [ Time Frame: Study days 47 to 60 ]
    Size of the chalazion will be assessed using a caliper and measured as height and width in mm.
  • Change in Chalazion Erythema [ Time Frame: Study days 47 to 60 ]
    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)
  • Pain Associated with the Chalazion [ Time Frame: Study days 47 to 60 ]
    Pain assessments will be done at the clinical site using a 100 mm visual analog scale.
  • Time to Complete Response of the Target Chalazion [ Time Frame: Study days 47 to 60 ]
  • Durability of Response [ Time Frame: Study days 47 to 60 ]
    Clinical assessment of the presence of a chalazion if there was a complete response by Day 23±2.
  • Comparison of Adverse Event Rates and Skin Irritation between Treatment Arms [ Time Frame: Day 23±2 ]


Original Secondary Outcome: Same as current

Information By: Senju USA, Inc.

Dates:
Date Received: October 31, 2014
Date Started: October 2014
Date Completion:
Last Updated: February 11, 2016
Last Verified: February 2016