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

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03527212
• Other study ID #: SJP-0035/3-01
• Status: Completed
• Phase: Phase 3
• Start date: August 20, 2018
• Est. completion date: March 15, 2019

Study information

• Verified date: April 2019
• Source: Senju Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• 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.

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Drug:
• 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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Senju Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   FDA Safety Alerts and Recalls