Study of DE-105 Ophthalmic Solution in Patients With Persistent Corneal Epithelial Defect

Phase 2

Completed

• Conditions: Persistent Corneal Epithelial Defect
• Interventions: Drug: DE-105 ophthalmic solution; Drug: Placebo ophthalmic solution

• Registration Number: NCT00988494
• Lead Sponsor: Santen Pharmaceutical Co., Ltd.

Brief Summary

Safety and efficacy of DE-105 ophthalmic solution in patients with persistent corneal epithelial defect will be evaluated. Dose-dependent efficacy will be evaluated as well.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-30
• Study First Submitted QC: 2009-10-01
• Study First Posted: 2009-10-02
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-21
• Last Update Posted: 2012-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Has corneal epithelial defect and decreased corneal sensitivity.
• Has undergone continuous treatment for corneal epithelial defect for 1 week or longer.

Exclusion Criteria

• Presence of disease such as active ocular infection, or abnormal lid closure.
• History or presence of chemical burn, Stevens - Johnson Syndrome, etc.
• History of corneal transplantation, LASIK, or hematopoietic stem cell transplantation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High concentration	DE-105 ophthalmic solution	DE-105 high concentration
Low concentration	DE-105 ophthalmic solution	DE-105 low concentration
Placebo	Placebo ophthalmic solution	DE-105 placebo

Primary Outcome Measures

Name	Time	Method
Restoration of corneal epithelial defect	Every week

Secondary Outcome Measures

Name	Time	Method
Visual acuity,etc.	Exit visit,etc.

Trial Locations

Locations (1)

Santen study sites; 🇯🇵 Osaka, Japan