Safety and Efficacy of SJP-0035 Ophthalmic Solution in Patients With Moderate to Severe Corneal Epithelial Disorders

A Double-Masked, Randomized, Multicenter, Placebo-Controlled, Parallel-Group Study of SJP-0035 Ophthalmic Solution Compared With Placebo to Assess Safety and Efficacy of Two Dose Concentrations of SJP-0035 Ophthalmic Solution for Corneal Epithelial Wound Healing in Patients With Moderate to Severe Corneal Epithelial Disorders

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.

Study Overview

• Status: Completed
• Conditions: Corneal Epithelial Disorders
• Intervention / Treatment: Drug: Low Dose SJP-0035 Ophthalmic Solution; Drug: High Dose SJP-0035 Ophthalmic Solution; Drug: Vehicle of SJP-0035 Ophthalmic solution

Detailed Description

There are currently no approved products available anywhere worldwide for the treatment of corneal epithelial disorders that directly affect the epithelia.

A Phase 1 study, Study SJP-0035/1-01, was conducted in healthy volunteers to investigate the safety, tolerability, and pharmacokinetic profile of SJP-0035 ophthalmic solution, and to determine the appropriate dose to be evaluated in patients with moderate to severe corneal epithelial disorders. A Phase 2a study, Study SJP-0035/2-01, was conducted in patients with corneal epithelial disorders to evaluate the efficacy and safety of SJP-0035.

This Phase 2a study (Study SJP-0035/2-02) is being conducted to evaluate the safety and efficacy of 2 doses of SJP-0035 ophthalmic solution in patients with corneal epithelial disorders. The study will evaluate if SJP-0035 ophthalmic solution is able to promote corneal epithelial wound healing in patients with corneal epithelial disorders using 2 doses of SJP-0035 ophthalmic solution (0.0002% and 0.001%) that are lower than what was used in the previous Phase 2a study (Study SJP-0035/2-01; 0.005%).

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Senju Investigational Site
  • California
    • Glendora, California, United States, 91741
      • Senju Investigational Site
    • Lancaster, California, United States, 93534
      • Senju Investigational Site
    • Long Beach, California, United States, 90805
      • Senju Investigational Site
    • Montebello, California, United States, 90640
      • Senju Investigational Site
    • Pasadena, California, United States, 91107
      • Senju Investigational Site
    • Santa Ana, California, United States, 92705
      • Senju Investigational Site
  • Florida
    • Miami, Florida, United States, 33143
      • Senju Investigational Site
  • Illinois
    • Hoffman Estates, Illinois, United States, 60169
      • Senju Investigational Site
  • Kentucky
    • Edgewood, Kentucky, United States, 41017
      • Senju Investigational Site
    • Louisville, Kentucky, United States, 40206
      • Senju Investigational Site
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Senju Investigational Site
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Senju Investigational Site
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Senju Investigational Site
  • Texas
    • Cedar Park, Texas, United States, 78613
      • Senju Investigational Site
    • Houston, Texas, United States, 77030
      • Senju Investigational Site
    • Irving, Texas, United States, 75039
      • Senju Investigational Site
  • Virginia
    • Falls Church, Virginia, United States, 22044
      • Senju Investigational Site
    • Norfolk, Virginia, United States, 23502
      • Senju Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low Dose SJP-0035 Ophthalmic solution; 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; 0.0002% SJP-0035 Ophthalmic Solution
Experimental: High Dose SJP-0035 Ophthalmic solution; 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; 0.001% SJP-0035 Ophthalmic Solution
Placebo Comparator: Vehicle of SJP-0035 Ophthalmic solution; 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; 0% SJP-0035 Ophthalmic Solution; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Senju Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): May 3, 2017
• Study Completion (Actual): May 3, 2017

Study Registration Dates

• First Submitted: October 7, 2016
• First Submitted That Met QC Criteria: October 7, 2016
• First Posted (Estimate): October 11, 2016

Study Record Updates

• Last Update Posted (Actual): April 13, 2021
• Last Update Submitted That Met QC Criteria: March 23, 2021
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Ophthalmic Solutions; Pharmaceutical Solutions
• Other Study ID Numbers: SJP-0035/2-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes