Safety and Efficacy Study of Rebamipide 2% Ophthalmic Suspension in Patients With Dry Eye

NCT ID: NCT01027013

Last Updated: 2012-01-11

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

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2010-11-30

Brief Summary

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The purpose of this study is to evaluate the safety and efficacy of rebamipide 2% suspension for the treatment of patients with dry-eye.

Detailed Description

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Conditions

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Dry Eye Syndromes Keratoconjunctivitis Sicca

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 2% ophthalmic suspension

Group Type EXPERIMENTAL

rebamipide 2% ophthalmic suspension

Intervention Type DRUG

Instill one drop in each eye four times daily for 12 weeks.

Placebo eye drops

Group Type PLACEBO_COMPARATOR

placebo eye drops

Intervention Type DRUG

Instill one drop in each eye four times daily for 12 weeks.

Interventions

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rebamipide 2% ophthalmic suspension

Instill one drop in each eye four times daily for 12 weeks.

Intervention Type DRUG

placebo eye drops

Instill one drop in each eye four times daily for 12 weeks.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age 18 years and older
* Diagnosis of dry eye as defined by the protocol

Exclusion Criteria

* Ongoing ocular disease that may interfere with study parameters.
* Inability to stop using topical ophthalmic medications throughout the duration of the study
* Inability to stop the use of contact lenses for the duration of the study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Kubota Vision Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nancy Boman, MD, PhD

Role: STUDY_DIRECTOR

Kubota Vision Inc.

Locations

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The Eye Care Group, P.C.

Waterbury, Connecticut, United States

Site Status

Richard Eiferman, MD

Louisville, Kentucky, United States

Site Status

Central Maine Eye Care

Lewiston, Maine, United States

Site Status

Ora, Inc

Andover, Massachusetts, United States

Site Status

Total Eye Care, P.A.

Memphis, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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ACU-RED-203

Identifier Type: -

Identifier Source: org_study_id

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