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

Santen Pharmaceutical Co., Ltd.45 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Persistent Corneal Epithelial Defect

Interventions

DE-105 ophthalmic solutionDRUG

Topical ocular application

DE-105 ophthalmic solutionDRUG

Topical ocular application

Placebo ophthalmic solutionDRUG

Topical ocular application

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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.

Locations (1)

Santen study sites

Osaka, Japan

Outcomes

Primary Outcomes

Restoration of corneal epithelial defect

Time frame: Every week

Secondary Outcomes

Visual acuity,etc.

Time frame: Exit visit,etc.

Data from ClinicalTrials.gov

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