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

Persistent Corneal Epithelial Defect Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00988494
• Other study ID #: 01050807
• Status: Completed
• Phase: Phase 2
• First received: September 30, 2009
• Last updated: November 21, 2012
• Start date: September 2009

Study information

• Verified date: November 2012
• Source: Santen Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Persistent Corneal Epithelial Defect

Intervention

Drug:
• DE-105 ophthalmic solution
Topical ocular application
• DE-105 ophthalmic solution
Topical ocular application
• Placebo ophthalmic solution
Topical ocular application

Locations

Country	Name	City	State
Japan	Santen study sites	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Santen Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Restoration of corneal epithelial defect		Every week	No
Secondary	Visual acuity,etc.		Exit visit,etc.	No