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

2016-10-12 01:38:21 | BioPortfolio

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.

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Corneal Epithelial Disorders

Intervention

High Dose SJP-0035 Ophthalmic Solution, Low Dose SJP-0035 Ophthalmic Solution, Vehicle of SJP-0035 Ophthalmic solution

Location

Senju Investigational Site
Cedar Park
Texas
United States
78613

Status

Recruiting

Source

Senju Pharmaceutical Co., Ltd.

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-10-12T01:38:21-0400

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