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

Santen Pharmaceutical Co., Ltd.1 site in 1 country45 target enrollmentSeptember 2009

ConditionsPersistent Corneal Epithelial Defect

InterventionsDE-105 ophthalmic solution Placebo ophthalmic solution

DrugsDE-105 ophthalmic solution Placebo ophthalmic solution

Overview

Phase: Phase 2
Intervention: DE-105 ophthalmic solution
Conditions: Persistent Corneal Epithelial Defect
Sponsor: Santen Pharmaceutical Co., Ltd.
Enrollment: 45
Locations: 1
Primary Endpoint: Restoration of corneal epithelial defect
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2009

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Santen Pharmaceutical Co., Ltd.

Eligibility Criteria

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.