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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03527212
Other study ID # SJP-0035/3-01
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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.

Study Design


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
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