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

NCT ID: NCT00988494

Last Updated: 2012-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Brief Summary

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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

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Conditions

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Persistent Corneal Epithelial Defect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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High concentration

DE-105 high concentration

Group Type EXPERIMENTAL

DE-105 ophthalmic solution

Intervention Type DRUG

Topical ocular application

Low concentration

DE-105 low concentration

Group Type EXPERIMENTAL

DE-105 ophthalmic solution

Intervention Type DRUG

Topical ocular application

Placebo

DE-105 placebo

Group Type PLACEBO_COMPARATOR

Placebo ophthalmic solution

Intervention Type DRUG

Topical ocular application

Interventions

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DE-105 ophthalmic solution

Topical ocular application

Intervention Type DRUG

DE-105 ophthalmic solution

Topical ocular application

Intervention Type DRUG

Placebo ophthalmic solution

Topical ocular application

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Santen Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Locations

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Santen study sites

Osaka, , Japan

Site Status

Countries

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Japan

Other Identifiers

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01050807

Identifier Type: -

Identifier Source: org_study_id