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

Sponsor

Senju Pharmaceutical Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT03527212

Collaborator

(none)

329

Enrollment

Locations

Arms

6.8

Actual Duration (Months)

14.3

Patients Per Site

2.1

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndromes	Drug: SJP-0035 0.001% Drug: Placebo	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

329 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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)

Actual Study Start Date :

Aug 20, 2018

Actual Primary Completion Date :

Mar 15, 2019

Actual Study Completion Date :

Mar 15, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Corneal fluorescein staining [Week 5]
Number of patients showing complete clearing of corneal fluorescein staining, scored on the Baylor grading system.

Secondary Outcome Measures

Blurred vision [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

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