A Study to Assess the Safety and Effectiveness of SJP-0035 for the Treatment of Patients With Dry Eye Disease
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)
1 other identifier
interventional
329
1 country
23
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2018
Shorter than P25 for phase_3
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 4, 2018
CompletedFirst Posted
Study publicly available on registry
May 17, 2018
CompletedStudy Start
First participant enrolled
August 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2019
CompletedApril 16, 2019
April 1, 2019
7 months
May 4, 2018
April 13, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Corneal fluorescein staining
Number of patients showing complete clearing of corneal fluorescein staining, scored on the Baylor grading system.
Week 5
Secondary Outcomes (1)
Blurred vision
Week 5
Study Arms (2)
SJP-0035 0.001% (ophthalmic solution)
EXPERIMENTALPlacebo (ophthalmic solution)
PLACEBO COMPARATORInterventions
Self-administration of 1 drop (approximately 40 µL) of 0.001% SJP-0035 ophthalmic solution into each eye 4 times daily for 4 weeks
Self-administration of 1 drop (approximately 40 µL) of placebo ophthalmic solution into each eye 4 times daily for 4 weeks
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Arizona Eye Center, 1500 West Ray Road
Chandler, Arizona, 85224, United States
Walman Eye Center, 10615 West Thunderbird Boulevard, Suite D180
Sun City, Arizona, 85351, United States
SoCal Eye Physicians and Associates Surgery Center, 3300 E. South Street
Long Beach, California, 90805, United States
East West Eye Institute, 420 East 3rd Street, Suite 603
Los Angeles, California, 90013, United States
North Valley Eye Medical Group, Inc., Suite 341, 11550 Indian Hills Road
Mission Hills, California, 91345, United States
North Bay Eye Associates, Inc., 104 Lynch Creek Way
Petaluma, California, 94954, United States
Sibia Eye Institute, Suite 1 & 2, 11195 Jog Road
Boynton Beach, Florida, 33437, United States
Clayton Eye Center, Suite 100 and 120, 1000 Corporate Center Drive
Morrow, Georgia, 30260, United States
Coastal Research Associates, LLC., Suite J3, 11205 Alpharetta Highway
Roswell, Georgia, 30076, United States
Chicago Cornea Consultants, Ltd., Suite 502, 1585 North Barrington Road
Hoffman Estates, Illinois, 60169, United States
The Eye Care Institute, 1536 Story Avenue
Louisville, Kentucky, 40206, United States
Chu Vision Institute, 9117 Lyndale Avenue South
Bloomington, Minnesota, 55420, United States
Tauber Eye Center, Suite 202, 4400 Broadway
Kansas City, Missouri, 64111, United States
Emil A. Stein, M.D., Ltd., Suite 100, 2090 East Flamingo Road
Las Vegas, Nevada, 89119, United States
Ophthalmic Consultants of Long Island, 3rd Floor, 360 Merrick Road
Lynbrook, New York, 11563, United States
South Shore Eye Care LLC, 2185 West Wantagh Avenue
Wantagh, New York, 11793, United States
Cornerstone Eye Care
High Point, North Carolina, 27262, United States
Black Hills Regional Eye Institute, 2800 3rd Street
Rapid City, South Dakota, 57701, United States
Hill Country Eye Center
Cedar Park, Texas, 78613, United States
Alkek Eye Center, 1977 Butler Boulevard
Houston, Texas, 77030, United States
R and R Eye Research, LLC., Suite 100, 5430 Fredericksburg Road
San Antonio, Texas, 78229, United States
Southern Utah Medical Research, Suite 100, 292 South 1470 East
St. George, Utah, 84790, United States
Virginia Eye Consultants, 241 Corporate Boulevard
Norfolk, Virginia, 23502, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2018
First Posted
May 17, 2018
Study Start
August 20, 2018
Primary Completion
March 15, 2019
Study Completion
March 15, 2019
Last Updated
April 16, 2019
Record last verified: 2019-04