Clinical trial NCT03527212: A Study to Assess the Safety and Effectiveness of SJP-0035 for the Treatment of Patients With Dry Eye Disease
Official title: A Double-Masked, Randomized, Multicenter, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of SJP-0035 0.001% for the Treatment of Patients With Dry Eye Disease (DELTA-1 Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Syndromes
Keywords: Dry Eye Disease
Corneal Epithelial Disorders
Re-Epithelialization
Lead sponsor: Senju Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-05-17
Enrollment: 329
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A double-masked, randomized, multi-center, placebo-controlled, parallel-group study in adult patients with Dry Eye Disease (DED). Patients will be randomly assigned to receive either SJP-0035 0.001% or placebo

Detailed description: There are currently no approved products available anywhere worldwide for the treatment of Dry Eye Disease (DED) that directly affect the corneal epithelium. This study will evaluate the safety and efficacy of SJP-0035 0.001%, compared with a placebo, on corneal healing. Patients meeting the requirements of the inclusion/exclusion criteria will administer 1 drop of the study drug/placebo 4 times per day for 4 weeks.

Eligibility criteria: Inclusion Criteria:

* Signed informed consent form (ICF).
* Has Dry Eye Disease (DED) with moderate to severe corneal fluorescein staining in both eyes.
* Has blurred vision caused by DED in both eyes.
* Women of childbearing potential must have negative serum pregnancy test results at Screening and Randomization and agree to use effective contraception throughout the study; post-menopausal women must have negative serum pregnancy test results at Screening and Randomization.
* Male participants must agree to use an acceptable form of contraception (i.e. a condom plus spermicide) and to refrain from sperm donation throughout the study.

Exclusion Criteria:

* Has any corneal stromal or endothelial abnormalities in either eye.
* Has any active or chronic allergic, bacterial or viral infection of ocular adnexa and eye structures in either eye.
* Has had eye surgery (including cataract, vitreous or eyelid surgery) in either eye within the last 28 days prior to first dose of study drug.
* Has had refractive surgery (including eye surface laser surgery) in either eye within the last 180 days prior to first dose of study drug.
* Has used any eye medication in either eye within 14 days prior to first dose of study drug, or is anticipated to require such medications during the study. Preservative-free artificial tears may be used up to 72 hours prior to the first dose in either eye.
* Is a contact lens wearer and cannot discontinue use in both eyes from Screening through the duration of the study.
* Has previously received SJP-0035 (study drug) in either eye.
* Currently has punctal occlusions, of any type, inserted into both superior and inferior puncta in either eye at Screening through the duration of the study.

Other protocol-defined inclusion/exclusion criteria could apply.

Primary outcomes:
measure: Corneal fluorescein staining
timeFrame: Week 5
Secondary outcomes:
measure: Blurred vision
timeFrame: Week 5
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Arizona Eye Center, 1500 West Ray Road
state: Arizona
city: Sun City
country: United States
facility: Walman Eye Center, 10615 West Thunderbird Boulevard, Suite D180
state: Arizona
city: Long Beach
country: United States
facility: SoCal Eye Physicians and Associates Surgery Center, 3300 E. South Street
state: California
city: Los Angeles
country: United States
facility: East West Eye Institute, 420 East 3rd Street, Suite 603
state: California
city: Mission Hills
country: United States
facility: North Valley Eye Medical Group, Inc., Suite 341, 11550 Indian Hills Road
state: California
city: Petaluma
country: United States
facility: North Bay Eye Associates, Inc., 104 Lynch Creek Way
state: California
city: Boynton Beach
country: United States
facility: Sibia Eye Institute, Suite 1 & 2, 11195 Jog Road
state: Florida
city: Morrow
country: United States
facility: Clayton Eye Center, Suite 100 and 120, 1000 Corporate Center Drive
state: Georgia
city: Roswell
country: United States
facility: Coastal Research Associates, LLC., Suite J3, 11205 Alpharetta Highway
state: Georgia
city: Hoffman Estates
country: United States
facility: Chicago Cornea Consultants, Ltd., Suite 502, 1585 North Barrington Road
state: Illinois
city: Louisville
country: United States
facility: The Eye Care Institute, 1536 Story Avenue
state: Kentucky
city: Bloomington
country: United States
facility: Chu Vision Institute, 9117 Lyndale Avenue South
state: Minnesota
city: Kansas City
country: United States
facility: Tauber Eye Center, Suite 202, 4400 Broadway
state: Missouri
city: Las Vegas
country: United States
facility: Emil A. Stein, M.D., Ltd., Suite 100, 2090 East Flamingo Road
state: Nevada
city: Lynbrook
country: United States
facility: Ophthalmic Consultants of Long Island, 3rd Floor, 360 Merrick Road
state: New York
city: Wantagh
country: United States
facility: South Shore Eye Care LLC, 2185 West Wantagh Avenue
state: New York
city: High Point
country: United States
facility: Cornerstone Eye Care
state: North Carolina
city: Rapid City
country: United States
facility: Black Hills Regional Eye Institute, 2800 3rd Street
state: South Dakota
city: Cedar Park
country: United States
facility: Hill Country Eye Center
state: Texas
city: Houston
country: United States
facility: Alkek Eye Center, 1977 Butler Boulevard
state: Texas
city: San Antonio
country: United States
facility: R and R Eye Research, LLC., Suite 100, 5430 Fredericksburg Road
state: Texas
city: Saint George
country: United States
facility: Southern Utah Medical Research, Suite 100, 292 South 1470 East
state: Utah
city: Norfolk
country: United States
facility: Virginia Eye Consultants, 241 Corporate Boulevard
state: Virginia
Study officials:
References: