Safety and Efficacy Study of Rebamipide 2% Ophthalmic Suspension in Subjects With Dry Eye - Effects on Central Cornea

Kubota Vision Inc.116 enrolled

Overview

The purpose of this study is to evaluate the safety and efficacy of 2% rebamipide compared to placebo in clearing of fluorescein staining of the central cornea in subjects with dry eye disease.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

116

Conditions

Keratoconjunctivitis Sicca Dry Eye

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 * Central corneal staining 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 (19)

East Valley Ophthalmology

Mesa, Arizona, United States

Arizona Center for Clinical Trials, LLC

Phoenix, Arizona, United States

Outcomes

Primary Outcomes

Central corneal clearing as measured by fluorescein staining

Time frame: 12 weeks

Secondary Outcomes

Ocular staining

Time frame: 12 weeks

Dry eye symptoms

Time frame: 12 weeks

Data from ClinicalTrials.gov

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