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

April 13, 2019 updated by: Senju Pharmaceutical Co., Ltd.

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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

329

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Arizona Eye Center, 1500 West Ray Road
      • Sun City, Arizona, United States, 85351
        • Walman Eye Center, 10615 West Thunderbird Boulevard, Suite D180
    • California
      • Long Beach, California, United States, 90805
        • SoCal Eye Physicians and Associates Surgery Center, 3300 E. South Street
      • Los Angeles, California, United States, 90013
        • East West Eye Institute, 420 East 3rd Street, Suite 603
      • Mission Hills, California, United States, 91345
        • North Valley Eye Medical Group, Inc., Suite 341, 11550 Indian Hills Road
      • Petaluma, California, United States, 94954
        • North Bay Eye Associates, Inc., 104 Lynch Creek Way
    • Florida
      • Boynton Beach, Florida, United States, 33437
        • Sibia Eye Institute, Suite 1 & 2, 11195 Jog Road
    • Georgia
      • Morrow, Georgia, United States, 30260
        • Clayton Eye Center, Suite 100 and 120, 1000 Corporate Center Drive
      • Roswell, Georgia, United States, 30076
        • Coastal Research Associates, LLC., Suite J3, 11205 Alpharetta Highway
    • Illinois
      • Hoffman Estates, Illinois, United States, 60169
        • Chicago Cornea Consultants, Ltd., Suite 502, 1585 North Barrington Road
    • Kentucky
      • Louisville, Kentucky, United States, 40206
        • The Eye Care Institute, 1536 Story Avenue
    • Minnesota
      • Bloomington, Minnesota, United States, 55420
        • Chu Vision Institute, 9117 Lyndale Avenue South
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Tauber Eye Center, Suite 202, 4400 Broadway
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • Emil A. Stein, M.D., Ltd., Suite 100, 2090 East Flamingo Road
    • New York
      • Lynbrook, New York, United States, 11563
        • Ophthalmic Consultants of Long Island, 3rd Floor, 360 Merrick Road
      • Wantagh, New York, United States, 11793
        • South Shore Eye Care LLC, 2185 West Wantagh Avenue
    • North Carolina
      • High Point, North Carolina, United States, 27262
        • Cornerstone Eye Care
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Black Hills Regional Eye Institute, 2800 3rd Street
    • Texas
      • Cedar Park, Texas, United States, 78613
        • Hill Country Eye Center
      • Houston, Texas, United States, 77030
        • Alkek Eye Center, 1977 Butler Boulevard
      • San Antonio, Texas, United States, 78229
        • R and R Eye Research, LLC., Suite 100, 5430 Fredericksburg Road
    • Utah
      • Saint George, Utah, United States, 84790
        • Southern Utah Medical Research, Suite 100, 292 South 1470 East
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Virginia Eye Consultants, 241 Corporate Boulevard

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: SJP-0035 0.001% (ophthalmic solution)
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_COMPARATOR: Placebo (ophthalmic solution)
Drug: Placebo
Self-administration of 1 drop (approximately 40 µL) of placebo ophthalmic solution into each eye 4 times daily for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Corneal fluorescein staining
Time Frame: Week 5
Number of patients showing complete clearing of corneal fluorescein staining, scored on the Baylor grading system.
Week 5

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blurred vision
Time Frame: Week 5
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Senju Pharmaceutical Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 20, 2018

Primary Completion (ACTUAL)

March 15, 2019

Study Completion (ACTUAL)

March 15, 2019

Study Registration Dates

First Submitted

May 4, 2018

First Submitted That Met QC Criteria

May 4, 2018

First Posted (ACTUAL)

May 17, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 16, 2019

Last Update Submitted That Met QC Criteria

April 13, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SJP-0035/3-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe