A Study to Assess the Safety and Effectiveness of SJP-0035 for the Treatment of Patients With Dry Eye Disease
- Conditions
- Dry Eye Syndromes
- Interventions
- Drug: SJP-0035 0.001%Drug: Placebo
- Registration Number
- NCT03527212
- Lead Sponsor
- Senju Pharmaceutical Co., Ltd.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 329
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SJP-0035 0.001% (ophthalmic solution) SJP-0035 0.001% - Placebo (ophthalmic solution) Placebo -
- Primary Outcome Measures
Name Time Method Corneal fluorescein staining Week 5 Number of patients showing complete clearing of corneal fluorescein staining, scored on the Baylor grading system.
- Secondary Outcome Measures
Name Time Method Blurred vision Week 5 Improvement in blurred vision from baseline, using a 100-point visual analog score (VAS) where 0 indicates no blurred vision and 100 indicates the worst possible blurred vision.
Trial Locations
- Locations (23)
Emil A. Stein, M.D., Ltd., Suite 100, 2090 East Flamingo Road
🇺🇸Las Vegas, Nevada, United States
North Bay Eye Associates, Inc., 104 Lynch Creek Way
🇺🇸Petaluma, California, United States
Alkek Eye Center, 1977 Butler Boulevard
🇺🇸Houston, Texas, United States
South Shore Eye Care LLC, 2185 West Wantagh Avenue
🇺🇸Wantagh, New York, United States
Clayton Eye Center, Suite 100 and 120, 1000 Corporate Center Drive
🇺🇸Morrow, Georgia, United States
Tauber Eye Center, Suite 202, 4400 Broadway
🇺🇸Kansas City, Missouri, United States
R and R Eye Research, LLC., Suite 100, 5430 Fredericksburg Road
🇺🇸San Antonio, Texas, United States
Coastal Research Associates, LLC., Suite J3, 11205 Alpharetta Highway
🇺🇸Roswell, Georgia, United States
Walman Eye Center, 10615 West Thunderbird Boulevard, Suite D180
🇺🇸Sun City, Arizona, United States
Arizona Eye Center, 1500 West Ray Road
🇺🇸Chandler, Arizona, United States
North Valley Eye Medical Group, Inc., Suite 341, 11550 Indian Hills Road
🇺🇸Mission Hills, California, United States
SoCal Eye Physicians and Associates Surgery Center, 3300 E. South Street
🇺🇸Long Beach, California, United States
East West Eye Institute, 420 East 3rd Street, Suite 603
🇺🇸Los Angeles, California, United States
The Eye Care Institute, 1536 Story Avenue
🇺🇸Louisville, Kentucky, United States
Sibia Eye Institute, Suite 1 & 2, 11195 Jog Road
🇺🇸Boynton Beach, Florida, United States
Chu Vision Institute, 9117 Lyndale Avenue South
🇺🇸Bloomington, Minnesota, United States
Chicago Cornea Consultants, Ltd., Suite 502, 1585 North Barrington Road
🇺🇸Hoffman Estates, Illinois, United States
Hill Country Eye Center
🇺🇸Cedar Park, Texas, United States
Virginia Eye Consultants, 241 Corporate Boulevard
🇺🇸Norfolk, Virginia, United States
Southern Utah Medical Research, Suite 100, 292 South 1470 East
🇺🇸Saint George, Utah, United States
Ophthalmic Consultants of Long Island, 3rd Floor, 360 Merrick Road
🇺🇸Lynbrook, New York, United States
Cornerstone Eye Care
🇺🇸High Point, North Carolina, United States
Black Hills Regional Eye Institute, 2800 3rd Street
🇺🇸Rapid City, South Dakota, United States