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

Kubota Vision Inc.220 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

220

Conditions

Dry Eye Syndromes Keratoconjunctivitis Sicca

Interventions

rebamipide 2% ophthalmic suspensionDRUG

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

placebo eye dropsDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (5)

The Eye Care Group, P.C.

Waterbury, Connecticut, United States

Richard Eiferman, MD

Louisville, Kentucky, United States

Central Maine Eye Care

Lewiston, Maine, United States

Ora, Inc

Andover, Massachusetts, United States

Outcomes

Primary Outcomes

Total fluorescein corneal staining score

Time frame: 4 weeks

Primary ocular discomfort

Time frame: 4 weeks

Secondary Outcomes

Dry eye symptoms

Time frame: 12 weeks

Ocular staining

Time frame: 12 weeks

Data from ClinicalTrials.gov

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