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

Last updated: August 3, 2021
Sponsor: Senju USA, Inc.
Overall Status: Completed

Phase

3

Condition

Eye Disease

Eye Disorders/infections

Treatment

N/A

Clinical Study ID

NCT03248440
SUN-131-03
  • Ages > 6
  • All Genders

Study 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 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  1. Chalazion that has atypical features (a recurring chalazion at the same spot, abnormalsurrounding 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, atopicdermatitis, 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 Design

Total Participants: 263
Study Start date:
July 31, 2017
Estimated Completion Date:
August 17, 2018

Connect with a study center

  • SUN-131-03 Investigational Site

    Chandler, Arizona 85225
    United States

    Site Not Available

  • SUN-131-03 Investigational Site

    Prescott, Arizona 86301
    United States

    Site Not Available

  • SUN-131-03 Investigational Site

    Sun City, Arizona 85351
    United States

    Site Not Available

  • SUN-131-03 Investigational Site

    Glendale, California 91204
    United States

    Site Not Available

  • SUN-131-03 Investigational Site

    Long Beach, California 90805
    United States

    Site Not Available

  • SUN-131-03 Investigational Site

    Los Angeles, California 90048
    United States

    Site Not Available

  • SUN-131-03 Investigational Site

    Mission Hills, California 91345
    United States

    Site Not Available

  • SUN-131-03 Investigational Site

    Petaluma, California 94954
    United States

    Site Not Available

  • SUN-131-03 Investigational Site

    Rancho Cordova, California 95670
    United States

    Site Not Available

  • SUN-131-03 Investigational Site

    San Diego, California 92115
    United States

    Site Not Available

  • SUN-131-03 Investigational Site

    Santa Ana, California 92705
    United States

    Site Not Available

  • SUN-131-03 Investigational Site

    Colorado Springs, Colorado 80907
    United States

    Site Not Available

  • SUN-131-03 Investigational Site

    Littleton, Colorado 80120
    United States

    Site Not Available

  • SUN-131-03 Investigational Site

    Fort Myers, Florida 33901
    United States

    Site Not Available

  • SUN-131-03 Investigational Site

    Largo, Florida 33773
    United States

    Site Not Available

  • SUN-131-03 Investigational Site

    Maitland, Florida 32751
    United States

    Site Not Available

  • SUN-131-03 Investigational Site

    Tamarac, Florida 33321
    United States

    Site Not Available

  • SUN-131-03 Investigational Site

    Albany, Georgia 31701
    United States

    Site Not Available

  • SUN-131-03 Investigational Site

    Morrow, Georgia 30260
    United States

    Site Not Available

  • SUN-131-03 Investigational Site

    Roswell, Georgia 30076
    United States

    Site Not Available

  • SUN-131-03 Investigational Site

    Chicago Ridge, Illinois 60415
    United States

    Site Not Available

  • SUN-131-03 Investigational Site

    Glenview, Illinois 60026
    United States

    Site Not Available

  • SUN-131-03 Investigational Site

    Hoffman Estates, Illinois 60169
    United States

    Site Not Available

  • SUN-131-03 Investigational Site

    Lake Villa, Illinois 60046
    United States

    Site Not Available

  • SUN-131-03 Investigational Site

    Leawood, Kansas 66211
    United States

    Site Not Available

  • SUN-131-03 Investigational Site

    Shawnee, Kansas 66204
    United States

    Site Not Available

  • SUN-131-03 Investigational Site

    Shawnee Mission, Kansas 66204
    United States

    Site Not Available

  • SUN-131-03 Investigational Site

    Lexington, Kentucky 40509
    United States

    Site Not Available

  • SUN-131-03 Investigational Site

    Louisville, Kentucky 40206
    United States

    Site Not Available

  • SUN-131-03 Investigational Site

    Saint Joseph, Michigan 49085
    United States

    Site Not Available

  • SUN-131-03 Investigational Site

    Bloomington, Minnesota 55420
    United States

    Site Not Available

  • SUN-131-03 Investigational Site

    Kansas City, Missouri 64133
    United States

    Site Not Available

  • SUN-131-03 Investigational Site

    Saint Louis, Missouri 63131
    United States

    Site Not Available

  • SUN-131-03 Investigational Site

    Washington, Missouri 63090
    United States

    Site Not Available

  • SUN-131-03 Investigational Site

    Las Vegas, Nevada 89119
    United States

    Site Not Available

  • SUN-131-03 Investigational Site

    Wantagh, New York 11793
    United States

    Site Not Available

  • SUN-131-03 Investigational Site

    Asheville, North Carolina 28803
    United States

    Site Not Available

  • SUN-131-03 Investigational Site

    Charlotte, North Carolina 28210
    United States

    Site Not Available

  • SUN-131-03 Investigational Site

    High Point, North Carolina 27262
    United States

    Site Not Available

  • SUN-131-03 Investigational Site

    Cincinnati, Ohio 45236
    United States

    Site Not Available

  • SUN-131-03 Investigational Site

    Mason, Ohio 45040
    United States

    Site Not Available

  • SUN-131-03 Investigational Site

    Lancaster, Pennsylvania 19087
    United States

    Site Not Available

  • SUN-131-03 Investigational Site

    Philadelphia, Pennsylvania 19148
    United States

    Site Not Available

  • SUN-131-03 Investigational Site

    Wayne, Pennsylvania 19087
    United States

    Site Not Available

  • SUN-131-03 Investigational Site

    Florence, South Carolina 29501
    United States

    Site Not Available

  • SUN-131-03 Investigational Site

    Rapid City, South Dakota 57701
    United States

    Site Not Available

  • SUN-131-03 Investigational Site

    Chattanooga, Tennessee 37411
    United States

    Site Not Available

  • SUN-131-03 Investigational Site

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • SUN-131-03 Investigational Site

    Nashville, Tennessee 37215
    United States

    Site Not Available

  • SUN-131-03 Investigational Site

    Cedar Park, Texas 78613
    United States

    Site Not Available

  • SUN-131-03 Investigational Site

    Houston, Texas 77034
    United States

    Site Not Available

  • SUN-131-03 Investigational Site

    Lakeway, Texas 78734
    United States

    Site Not Available

  • SUN-131-03 Investigational Site

    Mission, Texas 78572
    United States

    Site Not Available

  • SUN-131-03 Investigational Site

    San Antonio, Texas 78209
    United States

    Site Not Available

  • SUN-131-03 Investigational Site

    Salt Lake City, Utah 84117
    United States

    Site Not Available

  • SUN-131-03 Investigational Site

    Exmore, Virginia 23350
    United States

    Site Not Available

  • SUN-131-03 Investigational Site

    Falls Church, Virginia 22046
    United States

    Site Not Available

  • SUN-131-03 Investigational Site

    Norfolk, Virginia 23456
    United States

    Site Not Available

  • SUN-131-03 Investigational Site

    Racine, Wisconsin 53405
    United States

    Site Not Available

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