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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-05-03

Brief Summary

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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.

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Detailed Description

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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%).

Conditions

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Corneal Epithelial Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Low Dose SJP-0035 Ophthalmic Solution

Intervention Type DRUG

0.0002% SJP-0035 Ophthalmic Solution

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.

Group Type EXPERIMENTAL

High Dose SJP-0035 Ophthalmic Solution

Intervention Type DRUG

0.001% SJP-0035 Ophthalmic Solution

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

Group Type PLACEBO_COMPARATOR

Vehicle of SJP-0035 Ophthalmic solution

Intervention Type DRUG

0% SJP-0035 Ophthalmic Solution

Interventions

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High Dose SJP-0035 Ophthalmic Solution

0.001% SJP-0035 Ophthalmic Solution

Intervention Type DRUG

Low Dose SJP-0035 Ophthalmic Solution

0.0002% SJP-0035 Ophthalmic Solution

Intervention Type DRUG

Vehicle of SJP-0035 Ophthalmic solution

0% SJP-0035 Ophthalmic Solution

Intervention Type DRUG

Other Intervention Names

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Placebo

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No