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

NCT ID: NCT03248440

Last Updated: 2021-08-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

263 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-31

Study Completion Date

2018-08-17

Brief Summary

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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.

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Detailed Description

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Conditions

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Chalazion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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SUN-131 1.5% TDS

Group Type EXPERIMENTAL

SUN-131 1.5% TDS

Intervention Type DRUG

SUN-131 1.5% TDS will be worn for 14 days

Placebo TDS

Group Type PLACEBO_COMPARATOR

Placebo TDS

Intervention Type DRUG

No active substance; Placebo TDS will be worn each day for 14 days

Interventions

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SUN-131 1.5% TDS

SUN-131 1.5% TDS will be worn for 14 days

Intervention Type DRUG

Placebo TDS

No active substance; Placebo TDS will be worn each day for 14 days

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Senju USA, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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SUN-131-03 Investigational Site

Chandler, Arizona, United States

Site Status

SUN-131-03 Investigational Site

Prescott, Arizona, United States

Site Status

SUN-131-03 Investigational Site

Sun City, Arizona, United States

Site Status

SUN-131-03 Investigational Site

Glendale, California, United States

Site Status

SUN-131-03 Investigational Site

Lancaster, California, United States

Site Status

SUN-131-03 Investigational Site

Long Beach, California, United States

Site Status

SUN-131-03 Investigational Site

Los Angeles, California, United States

Site Status

SUN-131-03 Investigational Site

Mission Hills, California, United States

Site Status

SUN-131-03 Investigational Site

Petaluma, California, United States

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SUN-131-03 Investigational Site

Rancho Cordova, California, United States

Site Status

SUN-131-03 Investigational Site

San Diego, California, United States

Site Status

SUN-131-03 Investigational Site

Santa Ana, California, United States

Site Status

SUN-131-03 Investigational Site

Colorado Springs, Colorado, United States

Site Status

SUN-131-03 Investigational Site

Littleton, Colorado, United States

Site Status

SUN-131-03 Investigational Site

Fort Myers, Florida, United States

Site Status

SUN-131-03 Investigational Site

Largo, Florida, United States

Site Status

SUN-131-03 Investigational Site

Maitland, Florida, United States

Site Status

SUN-131-03 Investigational Site

Tamarac, Florida, United States

Site Status

SUN-131-03 Investigational Site

Albany, Georgia, United States

Site Status

SUN-131-03 Investigational Site

Morrow, Georgia, United States

Site Status

SUN-131-03 Investigational Site

Roswell, Georgia, United States

Site Status

SUN-131-03 Investigational Site

Chicago Ridge, Illinois, United States

Site Status

SUN-131-03 Investigational Site

Glenview, Illinois, United States

Site Status

SUN-131-03 Investigational Site

Hoffman Estates, Illinois, United States

Site Status

SUN-131-03 Investigational Site

Lake Villa, Illinois, United States

Site Status

SUN-131-03 Investigational Site

Leawood, Kansas, United States

Site Status

SUN-131-03 Investigational Site

Shawnee Mission, Kansas, United States

Site Status

SUN-131-03 Investigational Site

Lexington, Kentucky, United States

Site Status

SUN-131-03 Investigational Site

Louisville, Kentucky, United States

Site Status

SUN-131-03 Investigational Site

Saint Joseph, Michigan, United States

Site Status

SUN-131-03 Investigational Site

Bloomington, Minnesota, United States

Site Status

SUN-131-03 Investigational Site

Kansas City, Missouri, United States

Site Status

SUN-131-03 Investigational Site

St Louis, Missouri, United States

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SUN-131-03 Investigational Site

Washington, Missouri, United States

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SUN-131-03 Investigational Site

Las Vegas, Nevada, United States

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SUN-131-03 Investigational Site

Las Vegas, Nevada, United States

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SUN-131-03 Investigational Site

Wantagh, New York, United States

Site Status

SUN-131-03 Investigational Site

Asheville, North Carolina, United States

Site Status

SUN-131-03 Investigational Site

Charlotte, North Carolina, United States

Site Status

SUN-131-03 Investigational Site

High Point, North Carolina, United States

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SUN-131-03 Investigational Site

Cincinnati, Ohio, United States

Site Status

SUN-131-03 Investigational Site

Cincinnati, Ohio, United States

Site Status

SUN-131-03 Investigational Site

Mason, Ohio, United States

Site Status

SUN-131-03 Investigational Site

Lancaster, Pennsylvania, United States

Site Status

SUN-131-03 Investigational Site

Lancaster, Pennsylvania, United States

Site Status

SUN-131-03 Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

SUN-131-03 Investigational Site

Wayne, Pennsylvania, United States

Site Status

SUN-131-03 Investigational Site

Florence, South Carolina, United States

Site Status

SUN-131-03 Investigational Site

Rapid City, South Dakota, United States

Site Status

SUN-131-03 Investigational Site

Chattanooga, Tennessee, United States

Site Status

SUN-131-03 Investigational Site

Memphis, Tennessee, United States

Site Status

SUN-131-03 Investigational Site

Nashville, Tennessee, United States

Site Status

SUN-131-03 Investigational Site

Cedar Park, Texas, United States

Site Status

SUN-131-03 Investigational Site

Houston, Texas, United States

Site Status

SUN-131-03 Investigational Site

Houston, Texas, United States

Site Status

SUN-131-03 Investigational Site

Houston, Texas, United States

Site Status

SUN-131-03 Investigational Site

Lakeway, Texas, United States

Site Status

SUN-131-03 Investigational Site

Mission, Texas, United States

Site Status

SUN-131-03 Investigational Site

San Antonio, Texas, United States

Site Status

SUN-131-03 Investigational Site

San Antonio, Texas, United States

Site Status

SUN-131-03 Investigational Site

Salt Lake City, Utah, United States

Site Status

SUN-131-03 Investigational Site

Exmore, Virginia, United States

Site Status

SUN-131-03 Investigational Site

Falls Church, Virginia, United States

Site Status

SUN-131-03 Investigational Site

Norfolk, Virginia, United States

Site Status

SUN-131-03 Investigational Site

Racine, Wisconsin, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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SUN-131-03

Identifier Type: -

Identifier Source: org_study_id

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