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

Santen

Status and phase: Completed; Phase 2

Conditions: Persistent Corneal Epithelial Defect

Treatments: Drug: DE-105 ophthalmic solution; Drug: Placebo ophthalmic solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT00988494

01050807

Details and patient eligibility

About

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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45 participants in 3 patient groups, including a placebo group

High concentration

Experimental group

Description:

DE-105 high concentration

Treatment:

Drug: DE-105 ophthalmic solution

Drug: DE-105 ophthalmic solution

Low concentration

Experimental group

Description:

DE-105 low concentration

Treatment:

Drug: DE-105 ophthalmic solution

Drug: DE-105 ophthalmic solution

Placebo

Placebo Comparator group

Description:

DE-105 placebo

Treatment:

Drug: Placebo ophthalmic solution