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

Primary Purpose

Chalazion

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
SUN-131 1.5% TDS
Placebo TDS
Sponsored by
Senju USA, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chalazion

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • SUN-131-03 Investigational Site
  • SUN-131-03 Investigational Site
  • SUN-131-03 Investigational Site
  • SUN-131-03 Investigational Site
  • SUN-131-03 Investigational Site
  • SUN-131-03 Investigational Site
  • SUN-131-03 Investigational Site
  • SUN-131-03 Investigational Site
  • SUN-131-03 Investigational Site
  • SUN-131-03 Investigational Site
  • SUN-131-03 Investigational Site
  • SUN-131-03 Investigational Site
  • SUN-131-03 Investigational Site
  • SUN-131-03 Investigational Site
  • SUN-131-03 Investigational Site
  • SUN-131-03 Investigational Site
  • SUN-131-03 Investigational Site
  • SUN-131-03 Investigational Site
  • SUN-131-03 Investigational Site
  • SUN-131-03 Investigational Site
  • SUN-131-03 Investigational Site
  • SUN-131-03 Investigational Site
  • SUN-131-03 Investigational Site
  • SUN-131-03 Investigational Site
  • SUN-131-03 Investigational Site
  • SUN-131-03 Investigational Site
  • SUN-131-03 Investigational Site
  • SUN-131-03 Investigational Site
  • SUN-131-03 Investigational Site
  • SUN-131-03 Investigational Site
  • SUN-131-03 Investigational Site
  • SUN-131-03 Investigational Site
  • SUN-131-03 Investigational Site
  • SUN-131-03 Investigational Site
  • SUN-131-03 Investigational Site
  • SUN-131-03 Investigational Site
  • SUN-131-03 Investigational Site
  • SUN-131-03 Investigational Site
  • SUN-131-03 Investigational Site
  • SUN-131-03 Investigational Site
  • SUN-131-03 Investigational Site
  • SUN-131-03 Investigational Site
  • SUN-131-03 Investigational Site
  • SUN-131-03 Investigational Site
  • SUN-131-03 Investigational Site
  • SUN-131-03 Investigational Site
  • SUN-131-03 Investigational Site
  • SUN-131-03 Investigational Site
  • SUN-131-03 Investigational Site
  • SUN-131-03 Investigational Site
  • SUN-131-03 Investigational Site
  • SUN-131-03 Investigational Site
  • SUN-131-03 Investigational Site
  • SUN-131-03 Investigational Site
  • SUN-131-03 Investigational Site
  • SUN-131-03 Investigational Site
  • SUN-131-03 Investigational Site
  • SUN-131-03 Investigational Site
  • SUN-131-03 Investigational Site
  • SUN-131-03 Investigational Site
  • SUN-131-03 Investigational Site
  • SUN-131-03 Investigational Site
  • SUN-131-03 Investigational Site
  • SUN-131-03 Investigational Site
  • SUN-131-03 Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SUN-131 1.5% TDS

Placebo TDS

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 9, 2017
Last Updated
August 3, 2021
Sponsor
Senju USA, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03248440
Brief Title
Safety and Efficacy Study of SUN-131 Transdermal System (TDS) as Compared to Placebo TDS in Patients With a Chalazion
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
July 31, 2017 (Actual)
Primary Completion Date
August 17, 2018 (Actual)
Study Completion Date
August 17, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Senju USA, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chalazion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
263 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SUN-131 1.5% TDS
Arm Type
Experimental
Arm Title
Placebo TDS
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
SUN-131 1.5% TDS
Intervention Description
SUN-131 1.5% TDS will be worn for 14 days
Intervention Type
Drug
Intervention Name(s)
Placebo TDS
Intervention Description
No active substance; Placebo TDS will be worn each day for 14 days
Primary Outcome Measure Information:
Title
The Proportions of Participants Who Experienced Complete Response of the Study Chalazion by Day 15 ± 1
Description
Complete response was defined as the absence of any significant clinical signs of a chalazion, based on clinical judgment by an investigator.
Time Frame
Baseline to Day 15 ± 1
Secondary Outcome Measure Information:
Title
The Proportions of Participants Who Experienced Complete Response of the Study Chalazion With Upper Eyelid by Day 15 ± 1
Description
Complete response was defined as the absence of any significant clinical signs of a chalazion, based on clinical judgment by an investigator.
Time Frame
Baseline to Day 15 ± 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects aged ≥ 6 years of either sex and of any race Subjects with a diagnosis of a single chalazion Subjects with chalazion erythema score of ≥ 1 Normal eyelid function without active signs of eye and eyelid infection in either eye. Must be willing and able to correctly apply and wear a transdermal patch to the eyelid Avoid wearing contact lenses in the study eye Exclusion Criteria: Chalazion that has atypical features (a recurring chalazion at the same spot, abnormal surrounding lid tissue, associated loss of tissues). History of chalazion incision and curettage in study eyelid. Multiple chalazia in any one eyelid. Active ocular or eyelid infection Presence of hordeolum in any one eyelid. An abnormal skin condition on the study eyelid region (e.g., eczema, psoriasis, atopic dermatitis, etc.) where the study drug will be applied. Diagnosed with glaucoma in either eye. History of steroid-induced elevation of IOP. Female subjects who are pregnant or lactating.
Facility Information:
Facility Name
SUN-131-03 Investigational Site
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85225
Country
United States
Facility Name
SUN-131-03 Investigational Site
City
Prescott
State/Province
Arizona
ZIP/Postal Code
86301
Country
United States
Facility Name
SUN-131-03 Investigational Site
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
SUN-131-03 Investigational Site
City
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
Facility Name
SUN-131-03 Investigational Site
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Facility Name
SUN-131-03 Investigational Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90805
Country
United States
Facility Name
SUN-131-03 Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
SUN-131-03 Investigational Site
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
SUN-131-03 Investigational Site
City
Petaluma
State/Province
California
ZIP/Postal Code
94954
Country
United States
Facility Name
SUN-131-03 Investigational Site
City
Rancho Cordova
State/Province
California
ZIP/Postal Code
95670
Country
United States
Facility Name
SUN-131-03 Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92115
Country
United States
Facility Name
SUN-131-03 Investigational Site
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
SUN-131-03 Investigational Site
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
SUN-131-03 Investigational Site
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
SUN-131-03 Investigational Site
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
SUN-131-03 Investigational Site
City
Largo
State/Province
Florida
ZIP/Postal Code
33773
Country
United States
Facility Name
SUN-131-03 Investigational Site
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
SUN-131-03 Investigational Site
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
SUN-131-03 Investigational Site
City
Albany
State/Province
Georgia
ZIP/Postal Code
31701
Country
United States
Facility Name
SUN-131-03 Investigational Site
City
Morrow
State/Province
Georgia
ZIP/Postal Code
30260
Country
United States
Facility Name
SUN-131-03 Investigational Site
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
SUN-131-03 Investigational Site
City
Chicago Ridge
State/Province
Illinois
ZIP/Postal Code
60415
Country
United States
Facility Name
SUN-131-03 Investigational Site
City
Glenview
State/Province
Illinois
ZIP/Postal Code
60026
Country
United States
Facility Name
SUN-131-03 Investigational Site
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
SUN-131-03 Investigational Site
City
Lake Villa
State/Province
Illinois
ZIP/Postal Code
60046
Country
United States
Facility Name
SUN-131-03 Investigational Site
City
Leawood
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
SUN-131-03 Investigational Site
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66204
Country
United States
Facility Name
SUN-131-03 Investigational Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
SUN-131-03 Investigational Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40206
Country
United States
Facility Name
SUN-131-03 Investigational Site
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
SUN-131-03 Investigational Site
City
Bloomington
State/Province
Minnesota
ZIP/Postal Code
55420
Country
United States
Facility Name
SUN-131-03 Investigational Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64133
Country
United States
Facility Name
SUN-131-03 Investigational Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
SUN-131-03 Investigational Site
City
Washington
State/Province
Missouri
ZIP/Postal Code
63090
Country
United States
Facility Name
SUN-131-03 Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
SUN-131-03 Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89123
Country
United States
Facility Name
SUN-131-03 Investigational Site
City
Wantagh
State/Province
New York
ZIP/Postal Code
11793
Country
United States
Facility Name
SUN-131-03 Investigational Site
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
SUN-131-03 Investigational Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
SUN-131-03 Investigational Site
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
SUN-131-03 Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
SUN-131-03 Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45247
Country
United States
Facility Name
SUN-131-03 Investigational Site
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040
Country
United States
Facility Name
SUN-131-03 Investigational Site
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17601
Country
United States
Facility Name
SUN-131-03 Investigational Site
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
19087
Country
United States
Facility Name
SUN-131-03 Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19148
Country
United States
Facility Name
SUN-131-03 Investigational Site
City
Wayne
State/Province
Pennsylvania
ZIP/Postal Code
19087
Country
United States
Facility Name
SUN-131-03 Investigational Site
City
Florence
State/Province
South Carolina
ZIP/Postal Code
29501
Country
United States
Facility Name
SUN-131-03 Investigational Site
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
SUN-131-03 Investigational Site
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37411
Country
United States
Facility Name
SUN-131-03 Investigational Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
SUN-131-03 Investigational Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
Facility Name
SUN-131-03 Investigational Site
City
Cedar Park
State/Province
Texas
ZIP/Postal Code
78613
Country
United States
Facility Name
SUN-131-03 Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Facility Name
SUN-131-03 Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77034
Country
United States
Facility Name
SUN-131-03 Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77055
Country
United States
Facility Name
SUN-131-03 Investigational Site
City
Lakeway
State/Province
Texas
ZIP/Postal Code
78734
Country
United States
Facility Name
SUN-131-03 Investigational Site
City
Mission
State/Province
Texas
ZIP/Postal Code
78572
Country
United States
Facility Name
SUN-131-03 Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
Facility Name
SUN-131-03 Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
SUN-131-03 Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84117
Country
United States
Facility Name
SUN-131-03 Investigational Site
City
Exmore
State/Province
Virginia
ZIP/Postal Code
23350
Country
United States
Facility Name
SUN-131-03 Investigational Site
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22046
Country
United States
Facility Name
SUN-131-03 Investigational Site
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23456
Country
United States
Facility Name
SUN-131-03 Investigational Site
City
Racine
State/Province
Wisconsin
ZIP/Postal Code
53405
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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