Safety and Efficacy Study of SUN-131 Transdermal System (TDS) as Compared to Placebo TDS in Patients With a Chalazion (SUNRISE)

August 3, 2021 updated by: Senju USA, Inc.

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 Patients With a Chalazion (SUN-131-03)

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

263

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Chandler, Arizona, United States, 85225
        • SUN-131-03 Investigational Site
      • Prescott, Arizona, United States, 86301
        • SUN-131-03 Investigational Site
      • Sun City, Arizona, United States, 85351
        • SUN-131-03 Investigational Site
    • California
      • Glendale, California, United States, 91204
        • SUN-131-03 Investigational Site
      • Lancaster, California, United States, 93534
        • SUN-131-03 Investigational Site
      • Long Beach, California, United States, 90805
        • SUN-131-03 Investigational Site
      • Los Angeles, California, United States, 90048
        • SUN-131-03 Investigational Site
      • Mission Hills, California, United States, 91345
        • SUN-131-03 Investigational Site
      • Petaluma, California, United States, 94954
        • SUN-131-03 Investigational Site
      • Rancho Cordova, California, United States, 95670
        • SUN-131-03 Investigational Site
      • San Diego, California, United States, 92115
        • SUN-131-03 Investigational Site
      • Santa Ana, California, United States, 92705
        • SUN-131-03 Investigational Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • SUN-131-03 Investigational Site
      • Littleton, Colorado, United States, 80120
        • SUN-131-03 Investigational Site
    • Florida
      • Fort Myers, Florida, United States, 33901
        • SUN-131-03 Investigational Site
      • Largo, Florida, United States, 33773
        • SUN-131-03 Investigational Site
      • Maitland, Florida, United States, 32751
        • SUN-131-03 Investigational Site
      • Tamarac, Florida, United States, 33321
        • SUN-131-03 Investigational Site
    • Georgia
      • Albany, Georgia, United States, 31701
        • SUN-131-03 Investigational Site
      • Morrow, Georgia, United States, 30260
        • SUN-131-03 Investigational Site
      • Roswell, Georgia, United States, 30076
        • SUN-131-03 Investigational Site
    • Illinois
      • Chicago Ridge, Illinois, United States, 60415
        • SUN-131-03 Investigational Site
      • Glenview, Illinois, United States, 60026
        • SUN-131-03 Investigational Site
      • Hoffman Estates, Illinois, United States, 60169
        • SUN-131-03 Investigational Site
      • Lake Villa, Illinois, United States, 60046
        • SUN-131-03 Investigational Site
    • Kansas
      • Leawood, Kansas, United States, 66211
        • SUN-131-03 Investigational Site
      • Shawnee Mission, Kansas, United States, 66204
        • SUN-131-03 Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • SUN-131-03 Investigational Site
      • Louisville, Kentucky, United States, 40206
        • SUN-131-03 Investigational Site
    • Michigan
      • Saint Joseph, Michigan, United States, 49085
        • SUN-131-03 Investigational Site
    • Minnesota
      • Bloomington, Minnesota, United States, 55420
        • SUN-131-03 Investigational Site
    • Missouri
      • Kansas City, Missouri, United States, 64133
        • SUN-131-03 Investigational Site
      • Saint Louis, Missouri, United States, 63131
        • SUN-131-03 Investigational Site
      • Washington, Missouri, United States, 63090
        • SUN-131-03 Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • SUN-131-03 Investigational Site
      • Las Vegas, Nevada, United States, 89123
        • SUN-131-03 Investigational Site
    • New York
      • Wantagh, New York, United States, 11793
        • SUN-131-03 Investigational Site
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • SUN-131-03 Investigational Site
      • Charlotte, North Carolina, United States, 28210
        • SUN-131-03 Investigational Site
      • High Point, North Carolina, United States, 27262
        • SUN-131-03 Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45236
        • SUN-131-03 Investigational Site
      • Cincinnati, Ohio, United States, 45247
        • SUN-131-03 Investigational Site
      • Mason, Ohio, United States, 45040
        • SUN-131-03 Investigational Site
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17601
        • SUN-131-03 Investigational Site
      • Lancaster, Pennsylvania, United States, 19087
        • SUN-131-03 Investigational Site
      • Philadelphia, Pennsylvania, United States, 19148
        • SUN-131-03 Investigational Site
      • Wayne, Pennsylvania, United States, 19087
        • SUN-131-03 Investigational Site
    • South Carolina
      • Florence, South Carolina, United States, 29501
        • SUN-131-03 Investigational Site
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • SUN-131-03 Investigational Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37411
        • SUN-131-03 Investigational Site
      • Memphis, Tennessee, United States, 38119
        • SUN-131-03 Investigational Site
      • Nashville, Tennessee, United States, 37215
        • SUN-131-03 Investigational Site
    • Texas
      • Cedar Park, Texas, United States, 78613
        • SUN-131-03 Investigational Site
      • Houston, Texas, United States, 77008
        • SUN-131-03 Investigational Site
      • Houston, Texas, United States, 77034
        • SUN-131-03 Investigational Site
      • Houston, Texas, United States, 77055
        • SUN-131-03 Investigational Site
      • Lakeway, Texas, United States, 78734
        • SUN-131-03 Investigational Site
      • Mission, Texas, United States, 78572
        • SUN-131-03 Investigational Site
      • San Antonio, Texas, United States, 78209
        • SUN-131-03 Investigational Site
      • San Antonio, Texas, United States, 78240
        • SUN-131-03 Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84117
        • SUN-131-03 Investigational Site
    • Virginia
      • Exmore, Virginia, United States, 23350
        • SUN-131-03 Investigational Site
      • Falls Church, Virginia, United States, 22046
        • SUN-131-03 Investigational Site
      • Norfolk, Virginia, United States, 23456
        • SUN-131-03 Investigational Site
    • Wisconsin
      • Racine, Wisconsin, United States, 53405
        • SUN-131-03 Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subjects aged ≥ 6 years of either sex and of any race
  2. Subjects with a diagnosis of a single chalazion
  3. Subjects with chalazion erythema score of ≥ 1
  4. Normal eyelid function without active signs of eye and eyelid infection in either eye.
  5. Must be willing and able to correctly apply and wear a transdermal patch to the eyelid
  6. Avoid wearing contact lenses in the study eye

Exclusion Criteria:

  1. Chalazion that has atypical features (a recurring chalazion at the same spot, abnormal surrounding lid tissue, associated loss of tissues).
  2. History of chalazion incision and curettage in study eyelid.
  3. Multiple chalazia in any one eyelid.
  4. Active ocular or eyelid infection Presence of hordeolum in any one eyelid.
  5. An abnormal skin condition on the study eyelid region (e.g., eczema, psoriasis, atopic dermatitis, etc.) where the study drug will be applied.
  6. Diagnosed with glaucoma in either eye.
  7. History of steroid-induced elevation of IOP.
  8. Female subjects who are pregnant or lactating.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SUN-131 1.5% TDS
Drug: SUN-131 1.5% TDS
SUN-131 1.5% TDS will be worn for 14 days
Placebo Comparator: Placebo TDS
Drug: Placebo TDS
No active substance; Placebo TDS will be worn each day for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Proportions of Participants Who Experienced Complete Response of the Study Chalazion by Day 15 ± 1
Time Frame: Baseline to 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.
Baseline to Day 15 ± 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Proportions of Participants Who Experienced Complete Response of the Study Chalazion With Upper Eyelid by Day 15 ± 1
Time Frame: Baseline to 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.
Baseline to Day 15 ± 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Senju USA, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2017

Primary Completion (Actual)

August 17, 2018

Study Completion (Actual)

August 17, 2018

Study Registration Dates

First Submitted

August 9, 2017

First Submitted That Met QC Criteria

August 9, 2017

First Posted (Actual)

August 14, 2017

Study Record Updates

Last Update Posted (Actual)

August 5, 2021

Last Update Submitted That Met QC Criteria

August 3, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SUN-131-03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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