A Study to Assess the Safety and Effectiveness of SJP-0035 for the Treatment of Patients With Dry Eye Disease

Completed · Phase 3 · Has a placebo group

Conditions studied: Dry Eye Syndromes

In brief

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

Key facts

Study ID

NCT03527212

Run by

Senju Pharmaceutical Co., Ltd.

People needed

329

Starts

2018-08-20

Expected to finish

2019-03-15

Last updated by the study team

2019-04-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.