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

Chalazion Clinical Trial

— SUNRISE  

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 Patients With a Chalazion (SUN-131-03)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03248440
• Other study ID #: SUN-131-03
• Status: Completed
• Phase: Phase 3
• 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
• 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.

Related Conditions & MeSH terms

• Chalazion

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