Confirmatory Study of OPC-12759 Ophthalmic Solution

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

209 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-05-31

Brief Summary

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The purpose of this study is to verify whether OPC-12759 ophthalmic solution is effective compared with placebo in dry eye patients. OPC-12759 ophthalmic suspension will be used as a reference drug.

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Detailed Description

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Conditions

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Dry Eye

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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OPC-12759 ophthalmic solution

Group Type EXPERIMENTAL

OPC-12759

Intervention Type DRUG

Instillation, 4 times/day for 4 weeks

Placebo

OPC-12759 ophthalmic solution 0%

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

OPC-12759 ophthalmic suspension

Group Type ACTIVE_COMPARATOR

OPC-12759

Intervention Type DRUG

Instillation, 4 times/day for 4 weeks

Interventions

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OPC-12759

Instillation, 4 times/day for 4 weeks

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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rebamipide

Eligibility Criteria

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Inclusion Criteria

1. Out patient
2. Subjective complaint of dry eye that has been present for minimum 20 months
3. Ocular discomfort severity is moderate to severe
4. Corneal - conjunctival damage is moderate to severe
5. Unanesthetized Schirmer's test score of 5mm/5minutes or less
6. Best corrected visual acuity of 0.2 or better in both eyes

Exclusion Criteria

1. Presence of anterior segment disease or disorder other than that associated with dry eye
2. Ocular hypertension patient or glaucoma patient with ophthalmic solution
3. Anticipated use of any topically-instilled ocular medications or patients who cannot discontinue the use during the study
4. Anticipated use of contact lens during the study
5. Patient with punctal plug
6. Any history of ocular surgery within 12 months
7. Female patients who are pregnant,possibly pregnant or breast feeding
8. Known hypersensitivity to any component of the study drug or procedural medications
9. Receipt of any investigational product within 4 months.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No