Long Term Administration 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

PHASE3

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-01-31

Brief Summary

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The purpose of this study is to evaluate safety and efficacy of OPC-12759 ophthalmic suspension during 52 weeks in dry eye patients

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Detailed Description

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Conditions

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Dry Eye Syndromes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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OPC-12759 Ophthalmic suspension

Instillation, 4times/day

Group Type EXPERIMENTAL

OPC-12759 Ophthalmic suspension

Intervention Type DRUG

Instillation,4times/day,for 52weeks

Interventions

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OPC-12759 Ophthalmic suspension

Instillation,4times/day,for 52weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Out patient;
2. Ocular discomfort severity is moderate to severe;
3. Corneal-conjunctival damage is moderate to severe;
4. Unanesthetized Schirmer's test score of 5mm/5minutes or less,or tear breakup time is 5 seconds or less;
5. 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 scicca;
2. Ocular hypertention 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 procedual medications;
9. Receipt of any investigational product within 4 months.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No