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

Dry Eye Syndromes Clinical Trial

Official title:

A Phase II, Prospective, Randomized, Double-masked, Parallel Group, Multi-center Study Assessing the Safety and Efficacy of 2% Rebamipide (OPC-12759) Compared to Placebo for the Treatment of Keratoconjunctivitis Sicca (Dry Eye)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01027013
• Other study ID #: ACU-RED-203
• Status: Completed
• Phase: Phase 2
• First received: December 4, 2009
• Last updated: January 9, 2012
• Start date: December 2009
• Est. completion date: November 2010

Study information

• Verified date: January 2012
• Source: Acucela Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: November 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis
• Keratoconjunctivitis Sicca

Intervention

Drug:
• rebamipide 2% ophthalmic suspension
Instill one drop in each eye four times daily for 12 weeks.
• placebo eye drops
Instill one drop in each eye four times daily for 12 weeks.

Locations

Country	Name	City	State
United States	Ora, Inc	Andover	Massachusetts
United States	Central Maine Eye Care	Lewiston	Maine
United States	Richard Eiferman, MD	Louisville	Kentucky
United States	Total Eye Care, P.A.	Memphis	Tennessee
United States	The Eye Care Group, P.C.	Waterbury	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Acucela Inc.	Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total fluorescein corneal staining score		4 weeks	No
Primary	Primary ocular discomfort		4 weeks	No
Secondary	Dry eye symptoms		12 weeks	No
Secondary	Ocular staining		12 weeks	No