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Confirmatory Study of OPC-12759 Ophthalmic Suspension

NCT ID: NCT00885079

Last Updated: 2013-12-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

188 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2010-04-30

Brief Summary

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The purpose of this study is to verify whether OPC-12759 ophthalmic suspension is effective compared with active control in dry eye patients.

Detailed Description

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Conditions

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Dry Eye Syndromes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Rebamipide

Instillation,4 times/day for 4 weeks

Group Type EXPERIMENTAL

OPC-12759 Ophthalmic suspension

Intervention Type DRUG

OPC-12759 Ophthalmic suspension 2%

Hyaluronate

Instillation,6 times/day for 4 weeks

Group Type ACTIVE_COMPARATOR

Hyalein Mini Ophthalmic solution

Intervention Type DRUG

Hyalein Mini Ophthalmic solution 0.1%

Interventions

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OPC-12759 Ophthalmic suspension

OPC-12759 Ophthalmic suspension 2%

Intervention Type DRUG

Hyalein Mini Ophthalmic solution

Hyalein Mini Ophthalmic solution 0.1%

Intervention Type DRUG

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 keratoconjunctivitis sicca
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

Sponsors

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Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eiji Murakami

Role: STUDY_CHAIR

OPCJ-DDO

Locations

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Kyushu region

Kagoshima, , Japan

Site Status

Chushikoku region

Matsuyama, , Japan

Site Status

Tokai region

Nagoya, , Japan

Site Status

Kansai region

Osaka, , Japan

Site Status

Kanto region

Tokyo, , Japan

Site Status

Countries

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Japan

Other Identifiers

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037E-08-001

Identifier Type: -

Identifier Source: org_study_id