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

Primary Purpose

Dry Eye Syndromes

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
SJP-0035 0.001%
Placebo
Sponsored by
Senju Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndromes focused on measuring Dry Eye Disease, Corneal Epithelial Disorders, Re-Epithelialization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Arizona Eye Center, 1500 West Ray Road
  • Walman Eye Center, 10615 West Thunderbird Boulevard, Suite D180
  • SoCal Eye Physicians and Associates Surgery Center, 3300 E. South Street
  • East West Eye Institute, 420 East 3rd Street, Suite 603
  • North Valley Eye Medical Group, Inc., Suite 341, 11550 Indian Hills Road
  • North Bay Eye Associates, Inc., 104 Lynch Creek Way
  • Sibia Eye Institute, Suite 1 & 2, 11195 Jog Road
  • Clayton Eye Center, Suite 100 and 120, 1000 Corporate Center Drive
  • Coastal Research Associates, LLC., Suite J3, 11205 Alpharetta Highway
  • Chicago Cornea Consultants, Ltd., Suite 502, 1585 North Barrington Road
  • The Eye Care Institute, 1536 Story Avenue
  • Chu Vision Institute, 9117 Lyndale Avenue South
  • Tauber Eye Center, Suite 202, 4400 Broadway
  • Emil A. Stein, M.D., Ltd., Suite 100, 2090 East Flamingo Road
  • Ophthalmic Consultants of Long Island, 3rd Floor, 360 Merrick Road
  • South Shore Eye Care LLC, 2185 West Wantagh Avenue
  • Cornerstone Eye Care
  • Black Hills Regional Eye Institute, 2800 3rd Street
  • Hill Country Eye Center
  • Alkek Eye Center, 1977 Butler Boulevard
  • R and R Eye Research, LLC., Suite 100, 5430 Fredericksburg Road
  • Southern Utah Medical Research, Suite 100, 292 South 1470 East
  • Virginia Eye Consultants, 241 Corporate Boulevard

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SJP-0035 0.001% (ophthalmic solution)

Placebo (ophthalmic solution)

Arm Description

Outcomes

Primary Outcome Measures

Corneal fluorescein staining
Number of patients showing complete clearing of corneal fluorescein staining, scored on the Baylor grading system.

Secondary Outcome Measures

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.

Full Information

First Posted
May 4, 2018
Last Updated
April 13, 2019
Sponsor
Senju Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03527212
Brief Title
A Study to Assess the Safety and Effectiveness of SJP-0035 for the Treatment of Patients With Dry Eye Disease
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
August 20, 2018 (Actual)
Primary Completion Date
March 15, 2019 (Actual)
Study Completion Date
March 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Senju Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes
Keywords
Dry Eye Disease, Corneal Epithelial Disorders, Re-Epithelialization

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
329 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SJP-0035 0.001% (ophthalmic solution)
Arm Type
Experimental
Arm Title
Placebo (ophthalmic solution)
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
SJP-0035 0.001%
Intervention Description
Self-administration of 1 drop (approximately 40 µL) of 0.001% SJP-0035 ophthalmic solution into each eye 4 times daily for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Self-administration of 1 drop (approximately 40 µL) of placebo ophthalmic solution into each eye 4 times daily for 4 weeks
Primary Outcome Measure Information:
Title
Corneal fluorescein staining
Description
Number of patients showing complete clearing of corneal fluorescein staining, scored on the Baylor grading system.
Time Frame
Week 5
Secondary Outcome Measure Information:
Title
Blurred vision
Description
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.
Time Frame
Week 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Arizona Eye Center, 1500 West Ray Road
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Walman Eye Center, 10615 West Thunderbird Boulevard, Suite D180
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
SoCal Eye Physicians and Associates Surgery Center, 3300 E. South Street
City
Long Beach
State/Province
California
ZIP/Postal Code
90805
Country
United States
Facility Name
East West Eye Institute, 420 East 3rd Street, Suite 603
City
Los Angeles
State/Province
California
ZIP/Postal Code
90013
Country
United States
Facility Name
North Valley Eye Medical Group, Inc., Suite 341, 11550 Indian Hills Road
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
North Bay Eye Associates, Inc., 104 Lynch Creek Way
City
Petaluma
State/Province
California
ZIP/Postal Code
94954
Country
United States
Facility Name
Sibia Eye Institute, Suite 1 & 2, 11195 Jog Road
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33437
Country
United States
Facility Name
Clayton Eye Center, Suite 100 and 120, 1000 Corporate Center Drive
City
Morrow
State/Province
Georgia
ZIP/Postal Code
30260
Country
United States
Facility Name
Coastal Research Associates, LLC., Suite J3, 11205 Alpharetta Highway
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Chicago Cornea Consultants, Ltd., Suite 502, 1585 North Barrington Road
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
The Eye Care Institute, 1536 Story Avenue
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40206
Country
United States
Facility Name
Chu Vision Institute, 9117 Lyndale Avenue South
City
Bloomington
State/Province
Minnesota
ZIP/Postal Code
55420
Country
United States
Facility Name
Tauber Eye Center, Suite 202, 4400 Broadway
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Emil A. Stein, M.D., Ltd., Suite 100, 2090 East Flamingo Road
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Ophthalmic Consultants of Long Island, 3rd Floor, 360 Merrick Road
City
Lynbrook
State/Province
New York
ZIP/Postal Code
11563
Country
United States
Facility Name
South Shore Eye Care LLC, 2185 West Wantagh Avenue
City
Wantagh
State/Province
New York
ZIP/Postal Code
11793
Country
United States
Facility Name
Cornerstone Eye Care
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Black Hills Regional Eye Institute, 2800 3rd Street
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Hill Country Eye Center
City
Cedar Park
State/Province
Texas
ZIP/Postal Code
78613
Country
United States
Facility Name
Alkek Eye Center, 1977 Butler Boulevard
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
R and R Eye Research, LLC., Suite 100, 5430 Fredericksburg Road
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Southern Utah Medical Research, Suite 100, 292 South 1470 East
City
Saint George
State/Province
Utah
ZIP/Postal Code
84790
Country
United States
Facility Name
Virginia Eye Consultants, 241 Corporate Boulevard
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.fda.gov/Safety/Recalls
Description
FDA Safety Alerts and Recalls

Learn more about this trial

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

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