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
Phase: PHASE2
Conditions: Corneal Epithelial Disorders
Sponsor: Senju Pharmaceutical Co., Ltd.

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.