Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03248440
Other study ID # SUN-131-03
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date July 31, 2017
Est. completion date August 17, 2018

Study information

Verified date August 2021
Source Senju USA, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 263
Est. completion date August 17, 2018
Est. primary completion date August 17, 2018
Accepts healthy volunteers No
Gender All
Age group 6 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
SUN-131 1.5% TDS
SUN-131 1.5% TDS will be worn for 14 days
Placebo TDS
No active substance; Placebo TDS will be worn each day for 14 days

Locations

Country Name City State
United States SUN-131-03 Investigational Site Albany Georgia
United States SUN-131-03 Investigational Site Asheville North Carolina
United States SUN-131-03 Investigational Site Bloomington Minnesota
United States SUN-131-03 Investigational Site Cedar Park Texas
United States SUN-131-03 Investigational Site Chandler Arizona
United States SUN-131-03 Investigational Site Charlotte North Carolina
United States SUN-131-03 Investigational Site Chattanooga Tennessee
United States SUN-131-03 Investigational Site Chicago Ridge Illinois
United States SUN-131-03 Investigational Site Cincinnati Ohio
United States SUN-131-03 Investigational Site Cincinnati Ohio
United States SUN-131-03 Investigational Site Colorado Springs Colorado
United States SUN-131-03 Investigational Site Exmore Virginia
United States SUN-131-03 Investigational Site Falls Church Virginia
United States SUN-131-03 Investigational Site Florence South Carolina
United States SUN-131-03 Investigational Site Fort Myers Florida
United States SUN-131-03 Investigational Site Glendale California
United States SUN-131-03 Investigational Site Glenview Illinois
United States SUN-131-03 Investigational Site High Point North Carolina
United States SUN-131-03 Investigational Site Hoffman Estates Illinois
United States SUN-131-03 Investigational Site Houston Texas
United States SUN-131-03 Investigational Site Houston Texas
United States SUN-131-03 Investigational Site Houston Texas
United States SUN-131-03 Investigational Site Kansas City Missouri
United States SUN-131-03 Investigational Site Lake Villa Illinois
United States SUN-131-03 Investigational Site Lakeway Texas
United States SUN-131-03 Investigational Site Lancaster Pennsylvania
United States SUN-131-03 Investigational Site Lancaster Pennsylvania
United States SUN-131-03 Investigational Site Lancaster California
United States SUN-131-03 Investigational Site Largo Florida
United States SUN-131-03 Investigational Site Las Vegas Nevada
United States SUN-131-03 Investigational Site Las Vegas Nevada
United States SUN-131-03 Investigational Site Leawood Kansas
United States SUN-131-03 Investigational Site Lexington Kentucky
United States SUN-131-03 Investigational Site Littleton Colorado
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 Louisville Kentucky
United States SUN-131-03 Investigational Site Maitland Florida
United States SUN-131-03 Investigational Site Mason Ohio
United States SUN-131-03 Investigational Site Memphis Tennessee
United States SUN-131-03 Investigational Site Mission Texas
United States SUN-131-03 Investigational Site Mission Hills California
United States SUN-131-03 Investigational Site Morrow Georgia
United States SUN-131-03 Investigational Site Nashville Tennessee
United States SUN-131-03 Investigational Site Norfolk Virginia
United States SUN-131-03 Investigational Site Petaluma California
United States SUN-131-03 Investigational Site Philadelphia Pennsylvania
United States SUN-131-03 Investigational Site Prescott Arizona
United States SUN-131-03 Investigational Site Racine Wisconsin
United States SUN-131-03 Investigational Site Rancho Cordova California
United States SUN-131-03 Investigational Site Rapid City South Dakota
United States SUN-131-03 Investigational Site Roswell Georgia
United States SUN-131-03 Investigational Site Saint Joseph Michigan
United States SUN-131-03 Investigational Site Saint Louis Missouri
United States SUN-131-03 Investigational Site Salt Lake City Utah
United States SUN-131-03 Investigational Site San Antonio Texas
United States SUN-131-03 Investigational Site San Antonio Texas
United States SUN-131-03 Investigational Site San Diego California
United States SUN-131-03 Investigational Site Santa Ana California
United States SUN-131-03 Investigational Site Shawnee Mission Kansas
United States SUN-131-03 Investigational Site Sun City Arizona
United States SUN-131-03 Investigational Site Tamarac Florida
United States SUN-131-03 Investigational Site Wantagh New York
United States SUN-131-03 Investigational Site Washington Missouri
United States SUN-131-03 Investigational Site Wayne Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Senju USA, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline to Day 15 ± 1
Secondary 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. Baseline to Day 15 ± 1
See also
  Status Clinical Trial Phase
Completed NCT01202747 - Evaluation of Screening Methods for Treatment of Meibomian Gland Dysfunction Phase 2/Phase 3
Completed NCT02338648 - Safety and Efficacy Study of SUN 131 TDS as Compared to Placebo TDS in Adult Patients With a Chalazion Phase 2
Completed NCT00420628 - Pediatric Zylet Safety and Efficacy Study Phase 4
Withdrawn NCT01763437 - Intralesional Tetracycline Injection in the Treatment of Chalazia Phase 0
Recruiting NCT05070611 - Efficacy of Intense Pulsed Light in the Treatment of Recurrent Chalazia N/A
Completed NCT00832130 - Treatment of Meibomian Gland Dysfunction and Evaporative Dry Eye N/A
Completed NCT04342507 - Probiotics for Treatment of Chalazion in Adults N/A
Completed NCT04322500 - Probiotics for Chalaziosis Treatment in Children N/A
Recruiting NCT02025023 - Local 5-Fluorouracil Injection for the Treatment of Chalazia: A Prospective, Comparative Study Phase 3
Recruiting NCT05512572 - Therapeutic Efficacy of Intense Pulsed Light in the Treatment of Chalazion N/A