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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
263

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 31, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 17, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 17, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 9, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 14, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 5, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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