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

NCT02929823 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2021-04-13

Study results available
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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.

Conditions

  • Corneal Epithelial Disorders

Interventions

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

Sponsors & Collaborators

  • Senju Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2017-05-03
Completion
2017-05-03

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02929823 on ClinicalTrials.gov