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

Phase 2

Completed

• Conditions: Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Interventions: Drug: rebamipide 2% ophthalmic suspension; Drug: placebo eye drops

• Registration Number: NCT01027013
• Lead Sponsor: Kubota Vision Inc.

Brief Summary

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

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2009-12-04
• Study First Submitted QC: 2009-12-04
• Study First Posted: 2009-12-07
• Primary Completion: 2010-10
• Study Completion: 2010-11
• Status Verified: 2012-01
• Disposition First Submitted: 2012-01-09
• Disposition First Submitted QC: 2012-01-09
• Last Update Submitted: 2012-01-09
• Disposition First Posted: 2012-01-11
• Last Update Posted: 2012-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rebamipide 2% ophthalmic suspension	rebamipide 2% ophthalmic suspension	-
Placebo eye drops	placebo eye drops	-

Primary Outcome Measures

Name	Time	Method
Primary ocular discomfort	4 weeks
Total fluorescein corneal staining score	4 weeks

Secondary Outcome Measures

Name	Time	Method
Dry eye symptoms	12 weeks
Ocular staining	12 weeks

Trial Locations

Locations (5)

The Eye Care Group, P.C.; 🇺🇸 Waterbury, Connecticut, United States

Total Eye Care, P.A.; 🇺🇸 Memphis, Tennessee, United States

Ora, Inc; 🇺🇸 Andover, Massachusetts, United States

Richard Eiferman, MD; 🇺🇸 Louisville, Kentucky, United States

Central Maine Eye Care; 🇺🇸 Lewiston, Maine, United States