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

Senju Pharmaceutical

Status and phase: Completed; Phase 2

Conditions: Corneal Epithelial Disorders

Treatments: Drug: Vehicle of SJP-0035 Ophthalmic solution; Drug: High Dose SJP-0035 Ophthalmic Solution; Drug: Low Dose SJP-0035 Ophthalmic Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT02929823

SJP-0035/2-02

Details and patient eligibility

About

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.

Full 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%).

Enrollment: 130 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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130 participants in 3 patient groups, including a placebo group

Low Dose SJP-0035 Ophthalmic solution

Experimental group

Description:

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

Treatment:

Drug: Low Dose SJP-0035 Ophthalmic Solution

High Dose SJP-0035 Ophthalmic solution

Experimental group

Description:

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

Treatment:

Drug: High Dose SJP-0035 Ophthalmic Solution

Vehicle of SJP-0035 Ophthalmic solution

Placebo Comparator group

Description:

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

Treatment:

Drug: Vehicle of SJP-0035 Ophthalmic solution