Exploratory Study of OPC-12759 Ophthalmic Suspension

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2012-12-31

Brief Summary

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The purpose of this study is to evaluate the efficacy of OPC-12759 ophthalmic suspension for patients with keratoconjunctival epithelial disorder compared with sodium hyaluronate. Also, safety of OPC-12759 is to be assessed.

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Detailed Description

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Conditions

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Keratoconjunctival Epithelial Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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OPC-12759 ophthalmic suspension

Group Type EXPERIMENTAL

OPC-12759 ophthalmic suspension

Intervention Type DRUG

OPC-12759 ophthalmic suspension 2%

Sodium hyaluronate ophthalmic solution

Group Type ACTIVE_COMPARATOR

Sodium hyaluronate ophthalmic solution

Intervention Type DRUG

Sodium hyaluronate ophthalmic solution 0.1%

Interventions

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OPC-12759 ophthalmic suspension

OPC-12759 ophthalmic suspension 2%

Intervention Type DRUG

Sodium hyaluronate ophthalmic solution

Sodium hyaluronate ophthalmic solution 0.1%

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Diagnosis of superficial punctate keratopathy, corneal erosion or persistent epithelial defect
2. Fluorescein corneal staining score of 3 or higher

Exclusion Criteria

1. Active ocular infection
2. Vernal keratoconjunctivitis
3. Recurrent corneal erosion
4. Physical irritation of eyelashes or relaxed bulbar conjunctiva to cornea or conjunctiva
5. Subjects who cannot discontinue or anticipate use of eye drops except for limited concomitant ones during the study. Soft-santear is allowed during the screening period.
6. Anticipated use of contact lens during the study.
7. Insertion of punctal plug or fall out of punctal plug within 3 months
8. Subjects who are judged by the investigator to be ineligible for the study because of a past or concurrent systemic disease.
9. Receipt of any investigational product within 4 months.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No