A Study to Assess the Safety and Effectiveness of SJP-0035 for the Treatment of Patients With Dry Eye Disease
NCT ID: NCT03527212
Last Updated: 2019-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
329 participants
INTERVENTIONAL
2018-08-20
2019-03-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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SJP-0035 0.001% (ophthalmic solution)
SJP-0035 0.001%
Self-administration of 1 drop (approximately 40 µL) of 0.001% SJP-0035 ophthalmic solution into each eye 4 times daily for 4 weeks
Placebo (ophthalmic solution)
Placebo
Self-administration of 1 drop (approximately 40 µL) of placebo ophthalmic solution into each eye 4 times daily for 4 weeks
Interventions
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SJP-0035 0.001%
Self-administration of 1 drop (approximately 40 µL) of 0.001% SJP-0035 ophthalmic solution into each eye 4 times daily for 4 weeks
Placebo
Self-administration of 1 drop (approximately 40 µL) of placebo ophthalmic solution into each eye 4 times daily for 4 weeks
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Senju Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Arizona Eye Center, 1500 West Ray Road
Chandler, Arizona, United States
Walman Eye Center, 10615 West Thunderbird Boulevard, Suite D180
Sun City, Arizona, 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
North Valley Eye Medical Group, Inc., Suite 341, 11550 Indian Hills Road
Mission Hills, California, United States
North Bay Eye Associates, Inc., 104 Lynch Creek Way
Petaluma, California, United States
Sibia Eye Institute, Suite 1 & 2, 11195 Jog Road
Boynton Beach, Florida, United States
Clayton Eye Center, Suite 100 and 120, 1000 Corporate Center Drive
Morrow, Georgia, United States
Coastal Research Associates, LLC., Suite J3, 11205 Alpharetta Highway
Roswell, Georgia, United States
Chicago Cornea Consultants, Ltd., Suite 502, 1585 North Barrington Road
Hoffman Estates, Illinois, United States
The Eye Care Institute, 1536 Story Avenue
Louisville, Kentucky, United States
Chu Vision Institute, 9117 Lyndale Avenue South
Bloomington, Minnesota, United States
Tauber Eye Center, Suite 202, 4400 Broadway
Kansas City, Missouri, United States
Emil A. Stein, M.D., Ltd., Suite 100, 2090 East Flamingo Road
Las Vegas, Nevada, United States
Ophthalmic Consultants of Long Island, 3rd Floor, 360 Merrick Road
Lynbrook, New York, United States
South Shore Eye Care LLC, 2185 West Wantagh Avenue
Wantagh, 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
Hill Country Eye Center
Cedar Park, Texas, United States
Alkek Eye Center, 1977 Butler Boulevard
Houston, Texas, United States
R and R Eye Research, LLC., Suite 100, 5430 Fredericksburg Road
San Antonio, Texas, United States
Southern Utah Medical Research, Suite 100, 292 South 1470 East
St. George, Utah, United States
Virginia Eye Consultants, 241 Corporate Boulevard
Norfolk, Virginia, United States
Countries
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Related Links
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FDA Safety Alerts and Recalls
Other Identifiers
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SJP-0035/3-01
Identifier Type: -
Identifier Source: org_study_id
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