NCT02929823

Brief Summary

The purpose of this study is to determine whether SJP-0035 ophthalmic solution is effective in promoting corneal epithelial wound healing in conditions associated with corneal epithelial disorders.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 7, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 11, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 3, 2017

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

June 12, 2018

Completed
Last Updated

April 13, 2021

Status Verified

May 1, 2018

Enrollment Period

8 months

First QC Date

October 7, 2016

Results QC Date

May 14, 2018

Last Update Submit

March 23, 2021

Conditions

Corneal Epithelial Disorders

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Clearing of Corneal Fluorescein Staining at Week 5 at Week 5

    A patient will be considered a success for clearing of corneal fluorescein staining if their fluorescein staining has disappeared

    5 weeks

Study Arms (3)

Low Dose SJP-0035 Ophthalmic solution

EXPERIMENTAL

Patients will administer 1 drop of 0.0002% SJP-0035 ophthalmic solution in the affected eye(s) 4 times daily for 4 weeks.

Drug: Low Dose SJP-0035 Ophthalmic Solution

High Dose SJP-0035 Ophthalmic solution

EXPERIMENTAL

Patients will administer 1 drop of 0.001% SJP-0035 ophthalmic solution in the affected eye(s) 4 times daily for 4 weeks.

Drug: High Dose SJP-0035 Ophthalmic Solution

Vehicle of SJP-0035 Ophthalmic solution

PLACEBO COMPARATOR

Patients will administer 1 drop of 0% SJP-0035 ophthalmic solution (consisting of the vehicle for the solution) in the affected eye(s) 4 times daily for 4 weeks

Drug: Vehicle of SJP-0035 Ophthalmic solution

Interventions

High Dose SJP-0035 Ophthalmic SolutionDRUG

0.001% SJP-0035 Ophthalmic Solution

High Dose SJP-0035 Ophthalmic solution
Low Dose SJP-0035 Ophthalmic SolutionDRUG

0.0002% SJP-0035 Ophthalmic Solution

Low Dose SJP-0035 Ophthalmic solution
Vehicle of SJP-0035 Ophthalmic solutionDRUG

0% SJP-0035 Ophthalmic Solution

Also known as: Placebo
Vehicle of SJP-0035 Ophthalmic solution

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Is capable of understanding the written informed consent form (ICF), provides signed and witnessed written ICF, and agrees to comply with protocol requirements, including all required study visits
  • Is a male or female 18 years of age or older
  • Has a moderate to severe corneal epithelial disorder in both eyes
  • Has blurred vision caused by corneal epithelial disorders in both eyes at Screening and Randomization
  • Is a female of childbearing potential with a negative pregnancy test result at Screening and Randomization and agrees to use effective contraception throughout the study, or is a postmenopausal woman with a negative pregnancy test result at Screening and Randomization

You may not qualify if:

  • Has any corneal stromal or endothelial abnormalities including an active bacterial or viral ocular infection, bullous keratopathy, chemical burns, or any trauma to the cornea in either eye at Screening and Randomization
  • Has any active or chronic allergic, bacterial, or viral infection of ocular adnexa and eye structures in either eye at Screening and Randomization
  • Has had intraocular surgery (including cataract or vitreous) in either eye within the last 30 days prior to the first dose of study drug
  • Has had refractive surgery (including ocular surface laser surgery) in either eye within the last 6 months prior to the first dose of study drug
  • Has used any ocular medication (except mydriatics, stain, and topical anesthesia used for study assessments) in either eye within 14 days prior to the first dose of study drug, or is anticipated to require such medications during the study.
  • Is a contact lens wearer and cannot discontinue use in both eyes from Screening through EOS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Senju Investigational Site

Little Rock, Arkansas, 72205, United States

Location

Senju Investigational Site

Glendora, California, 91741, United States

Location

Senju Investigational Site

Lancaster, California, 93534, United States

Location

Senju Investigational Site

Long Beach, California, 90805, United States

Location

Senju Investigational Site

Montebello, California, 90640, United States

Location

Senju Investigational Site

Pasadena, California, 91107, United States

Location

Senju Investigational Site

Santa Ana, California, 92705, United States

Location

Senju Investigational Site

Miami, Florida, 33143, United States

Location

Senju Investigational Site

Hoffman Estates, Illinois, 60169, United States

Location

Senju Investigational Site

Edgewood, Kentucky, 41017, United States

Location

Senju Investigational Site

Louisville, Kentucky, 40206, United States

Location

Senju Investigational Site

Kansas City, Missouri, 64111, United States

Location

Senju Investigational Site

High Point, North Carolina, 27262, United States

Location

Senju Investigational Site

Rapid City, South Dakota, 57701, United States

Location

Senju Investigational Site

Cedar Park, Texas, 78613, United States

Location

Senju Investigational Site

Houston, Texas, 77030, United States

Location

Senju Investigational Site

Irving, Texas, 75039, United States

Location

Senju Investigational Site

Falls Church, Virginia, 22044, United States

Location

Senju Investigational Site

Norfolk, Virginia, 23502, United States

Location

Results Point of Contact

Title
Joseph Pollard
Organization
PPD
joseph.pollard@ppdi.com
+1 910 558 4428

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2016

First Posted

October 11, 2016

Study Start

September 1, 2016

Primary Completion

May 3, 2017

Study Completion

May 3, 2017

Last Updated

April 13, 2021

Results First Posted

June 12, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will share

Locations

US(19)