Dry Eye Syndromes Clinical Trial
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)
Verified date | April 2019 |
Source | Senju Pharmaceutical Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 329 |
Est. completion date | March 15, 2019 |
Est. primary completion date | March 15, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Chu Vision Institute, 9117 Lyndale Avenue South | Bloomington | Minnesota |
United States | Sibia Eye Institute, Suite 1 & 2, 11195 Jog Road | Boynton Beach | Florida |
United States | Hill Country Eye Center | Cedar Park | Texas |
United States | Arizona Eye Center, 1500 West Ray Road | Chandler | Arizona |
United States | Cornerstone Eye Care | High Point | North Carolina |
United States | Chicago Cornea Consultants, Ltd., Suite 502, 1585 North Barrington Road | Hoffman Estates | Illinois |
United States | Alkek Eye Center, 1977 Butler Boulevard | Houston | Texas |
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 | 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 | Ophthalmic Consultants of Long Island, 3rd Floor, 360 Merrick Road | Lynbrook | New York |
United States | North Valley Eye Medical Group, Inc., Suite 341, 11550 Indian Hills Road | Mission Hills | California |
United States | Clayton Eye Center, Suite 100 and 120, 1000 Corporate Center Drive | Morrow | Georgia |
United States | Virginia Eye Consultants, 241 Corporate Boulevard | Norfolk | Virginia |
United States | North Bay Eye Associates, Inc., 104 Lynch Creek Way | Petaluma | California |
United States | Black Hills Regional Eye Institute, 2800 3rd Street | Rapid City | South Dakota |
United States | Coastal Research Associates, LLC., Suite J3, 11205 Alpharetta Highway | Roswell | Georgia |
United States | Southern Utah Medical Research, Suite 100, 292 South 1470 East | Saint George | Utah |
United States | R and R Eye Research, LLC., Suite 100, 5430 Fredericksburg Road | San Antonio | Texas |
United States | Walman Eye Center, 10615 West Thunderbird Boulevard, Suite D180 | Sun City | Arizona |
United States | South Shore Eye Care LLC, 2185 West Wantagh Avenue | Wantagh | New York |
Lead Sponsor | Collaborator |
---|---|
Senju Pharmaceutical Co., Ltd. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Corneal fluorescein staining | Number of patients showing complete clearing of corneal fluorescein staining, scored on the Baylor grading system. | Week 5 | |
Secondary | Blurred vision | 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. | Week 5 |
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