Clinical trial NCT03248440: Safety and Efficacy Study of SUN-131 Transdermal System (TDS) as Compared to Placebo TDS in Patients With a Chalazion
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chalazion
Lead sponsor: Senju USA, Inc.
Sponsor class: INDUSTRY
First posted: 2017-08-14
Enrollment: 263
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The Proportions of Participants Who Experienced Complete Response of the Study Chalazion by Day 15 ± 1
timeFrame: Baseline to Day 15 ± 1
Secondary outcomes:
measure: The Proportions of Participants Who Experienced Complete Response of the Study Chalazion With Upper Eyelid by Day 15 ± 1
timeFrame: Baseline to Day 15 ± 1
Other outcomes:
Locations:
city: Chandler
country: United States
facility: SUN-131-03 Investigational Site
state: Arizona
city: Prescott
country: United States
facility: SUN-131-03 Investigational Site
state: Arizona
city: Sun City
country: United States
facility: SUN-131-03 Investigational Site
state: Arizona
city: Glendale
country: United States
facility: SUN-131-03 Investigational Site
state: California
city: Lancaster
country: United States
facility: SUN-131-03 Investigational Site
state: California
city: Long Beach
country: United States
facility: SUN-131-03 Investigational Site
state: California
city: Los Angeles
country: United States
facility: SUN-131-03 Investigational Site
state: California
city: Mission Hills
country: United States
facility: SUN-131-03 Investigational Site
state: California
city: Petaluma
country: United States
facility: SUN-131-03 Investigational Site
state: California
city: Rancho Cordova
country: United States
facility: SUN-131-03 Investigational Site
state: California
city: San Diego
country: United States
facility: SUN-131-03 Investigational Site
state: California
city: Santa Ana
country: United States
facility: SUN-131-03 Investigational Site
state: California
city: Colorado Springs
country: United States
facility: SUN-131-03 Investigational Site
state: Colorado
city: Littleton
country: United States
facility: SUN-131-03 Investigational Site
state: Colorado
city: Fort Myers
country: United States
facility: SUN-131-03 Investigational Site
state: Florida
city: Largo
country: United States
facility: SUN-131-03 Investigational Site
state: Florida
city: Maitland
country: United States
facility: SUN-131-03 Investigational Site
state: Florida
city: Tamarac
country: United States
facility: SUN-131-03 Investigational Site
state: Florida
city: Albany
country: United States
facility: SUN-131-03 Investigational Site
state: Georgia
city: Morrow
country: United States
facility: SUN-131-03 Investigational Site
state: Georgia
city: Roswell
country: United States
facility: SUN-131-03 Investigational Site
state: Georgia
city: Chicago Ridge
country: United States
facility: SUN-131-03 Investigational Site
state: Illinois
city: Glenview
country: United States
facility: SUN-131-03 Investigational Site
state: Illinois
city: Hoffman Estates
country: United States
facility: SUN-131-03 Investigational Site
state: Illinois
city: Lake Villa
country: United States
facility: SUN-131-03 Investigational Site
state: Illinois
city: Leawood
country: United States
facility: SUN-131-03 Investigational Site
state: Kansas
city: Shawnee Mission
country: United States
facility: SUN-131-03 Investigational Site
state: Kansas
city: Lexington
country: United States
facility: SUN-131-03 Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: SUN-131-03 Investigational Site
state: Kentucky
city: Saint Joseph
country: United States
facility: SUN-131-03 Investigational Site
state: Michigan
city: Bloomington
country: United States
facility: SUN-131-03 Investigational Site
state: Minnesota
city: Kansas City
country: United States
facility: SUN-131-03 Investigational Site
state: Missouri
city: Saint Louis
country: United States
facility: SUN-131-03 Investigational Site
state: Missouri
city: Washington
country: United States
facility: SUN-131-03 Investigational Site
state: Missouri
city: Las Vegas
country: United States
facility: SUN-131-03 Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: SUN-131-03 Investigational Site
state: Nevada
city: Wantagh
country: United States
facility: SUN-131-03 Investigational Site
state: New York
city: Asheville
country: United States
facility: SUN-131-03 Investigational Site
state: North Carolina
city: Charlotte
country: United States
facility: SUN-131-03 Investigational Site
state: North Carolina
city: High Point
country: United States
facility: SUN-131-03 Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: SUN-131-03 Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: SUN-131-03 Investigational Site
state: Ohio
city: Mason
country: United States
facility: SUN-131-03 Investigational Site
state: Ohio
city: Lancaster
country: United States
facility: SUN-131-03 Investigational Site
state: Pennsylvania
city: Lancaster
country: United States
facility: SUN-131-03 Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: SUN-131-03 Investigational Site
state: Pennsylvania
city: Wayne
country: United States
facility: SUN-131-03 Investigational Site
state: Pennsylvania
city: Florence
country: United States
facility: SUN-131-03 Investigational Site
state: South Carolina
city: Rapid City
country: United States
facility: SUN-131-03 Investigational Site
state: South Dakota
city: Chattanooga
country: United States
facility: SUN-131-03 Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: SUN-131-03 Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: SUN-131-03 Investigational Site
state: Tennessee
city: Cedar Park
country: United States
facility: SUN-131-03 Investigational Site
state: Texas
city: Houston
country: United States
facility: SUN-131-03 Investigational Site
state: Texas
city: Houston
country: United States
facility: SUN-131-03 Investigational Site
state: Texas
city: Houston
country: United States
facility: SUN-131-03 Investigational Site
state: Texas
city: Lakeway
country: United States
facility: SUN-131-03 Investigational Site
state: Texas
city: Mission
country: United States
facility: SUN-131-03 Investigational Site
state: Texas
city: San Antonio
country: United States
facility: SUN-131-03 Investigational Site
state: Texas
city: San Antonio
country: United States
facility: SUN-131-03 Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: SUN-131-03 Investigational Site
state: Utah
city: Exmore
country: United States
facility: SUN-131-03 Investigational Site
state: Virginia
city: Falls Church
country: United States
facility: SUN-131-03 Investigational Site
state: Virginia
city: Norfolk
country: United States
facility: SUN-131-03 Investigational Site
state: Virginia
city: Racine
country: United States
facility: SUN-131-03 Investigational Site
state: Wisconsin
Study officials:
References: