A Study to Assess the Safety and Effectiveness of SJP-003... | NCT03527212

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 20, 2018Actual

Primary Completion Date

Mar 15, 2019Actual

Completion Date

Mar 15, 2019Actual

First Submitted Date

May 4, 2018

First Submission Date that Met QC Criteria

May 4, 2018

First Posted Date

May 17, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 13, 2019

Last Update Posted Date

Apr 16, 2019Actual

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

329Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SJP-0035 0.001% (ophthalmic solution)	Experimental		Drug: SJP-0035 0.001%
Placebo (ophthalmic solution)	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SJP-0035 0.001%	Drug	Self-administration of 1 drop (approximately 40 µL) of 0.001% SJP-0035 ophthalmic solution into each eye 4 times daily for 4 weeks	SJP-0035 0.001% (ophthalmic solution)

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Arizona Eye Center, 1500 West Ray Road		Chandler	Arizona	85224	United States
Walman Eye Center, 10615 West Thunderbird Boulevard, Suite D180

ID	Term
D007766	Lacrimal Apparatus Diseases
D005128	Eye Diseases