Conditions: Corneal Epithelial Disorders
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 130
Healthy volunteers: no

Brief 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%).

Arms:
arm 1: Patients will administer 1 drop of 0.0002% SJP-0035 ophthalmic solution in the affected eye(s) 4 times daily for 4 weeks. arm 2: Patients will administer 1 drop of 0.001% SJP-0035 ophthalmic solution in the affected eye(s) 4 times daily for 4 weeks. arm 3: 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

Interventions: intervention 1: High Dose SJP-0035 Ophthalmic Solution intervention 2: Low Dose SJP-0035 Ophthalmic Solution intervention 3: Vehicle of SJP-0035 Ophthalmic solution
Intervention descriptions: intervention 1: 0.001% SJP-0035 Ophthalmic Solution intervention 2: 0.0002% SJP-0035 Ophthalmic Solution intervention 3: 0% SJP-0035 Ophthalmic Solution

Protocol document:
Prot_SAP_000.pdf: 
4 
 
 
 
CLINICAL STUDY PROTOCOL 
IND 116542 
 
 
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 
 
 
 
PROTOCOL NO.: SJP-0035/2-02 
 
Sponsor: 
Senju Phannaceutical Co., Ltd. 
2-5-8, Hiranomachi, Chuo-Ku 
Osaka 541-0046,  Japan 
Sponsor  Contact: 
 
 
 
Version of Protocol:  
1.0 
 
 
Date of Protocol:  
27 April2016 
 
 
CONFIDENTIAL 
All financial and nonfinancial suppo1t for this study will be provided by Senju Pharmaceutical 
Co., Ltd. The concepts and info1mation contained in this document  or generated during the 
study are considered proprietary and may not be disclosed in whole or in part without the 
expressed,  written consent of Senju Pharmaceutical Co., Ltd. 
The sn1dy will be conducted according  to the Intemational Council on Harmonisation 
harmonised  tripa1tite guideline  E6(Rl): Good Clinical Practice. 


A redacted version of the Protocol, containing the Statistical Analysis Plan (SAP) is being 
prepared and will be uploaded in due course.