NCT02929823

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Senju Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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%).

Conditions

• Corneal Epithelial Disorders

Interventions

Type	Name	Description
DRUG	High Dose SJP-0035 Ophthalmic Solution	0.001% SJP-0035 Ophthalmic Solution
DRUG	Low Dose SJP-0035 Ophthalmic Solution	0.0002% SJP-0035 Ophthalmic Solution
DRUG	Vehicle of SJP-0035 Ophthalmic solution	0% SJP-0035 Ophthalmic Solution

Timeline

• Start date: 2016-09-01
• Primary completion: 2017-05-03
• Completion: 2017-05-03
• First posted: 2016-10-11
• Last updated: 2021-04-13
• Results posted: 2018-06-12

Locations

19 sites across 1 country: United States