Safety and Efficacy Study of Rebamipide 2% Ophthalmic Suspension in Patients With Dry Eye - Full Text View

Sponsor:	Acucela Inc.
Collaborator:	Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):	Acucela Inc.
ClinicalTrials.gov Identifier:	NCT01027013

Purpose

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

Condition	Intervention	Phase
Dry Eye Syndromes Keratoconjunctivitis Sicca	Drug: rebamipide 2% ophthalmic suspension Drug: placebo eye drops	Phase II

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

Resource links provided by NLM:

Drug Information available for: Tetrahydrozoline Rebamipide Tetrahydrozoline hydrochloride

U.S. FDA Resources

Further study details as provided by Acucela Inc.:

Primary Outcome Measures:

Total fluorescein corneal staining score [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Primary ocular discomfort [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Dry eye symptoms [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Ocular staining [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment:	220
Study Start Date:	December 2009
Study Completion Date:	November 2010
Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: rebamipide 2% ophthalmic suspension	Drug: rebamipide 2% ophthalmic suspension Instill one drop in each eye four times daily for 12 weeks.
Placebo Comparator: Placebo eye drops	Drug: placebo eye drops Instill one drop in each eye four times daily for 12 weeks.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01027013

Locations

United States, Connecticut
The Eye Care Group, P.C.
Waterbury, Connecticut, United States, 06708
United States, Kentucky
Richard Eiferman, MD
Louisville, Kentucky, United States, 40205
United States, Maine
Central Maine Eye Care
Lewiston, Maine, United States, 04240
United States, Massachusetts
Ora, Inc
Andover, Massachusetts, United States, 01810
United States, Tennessee
Total Eye Care, P.A.
Memphis, Tennessee, United States, 38119

Sponsors and Collaborators

Acucela Inc.

Otsuka Pharmaceutical Co., Ltd.

Investigators

Study Director:

Nancy Boman, MD, PhD

Acucela Inc.

More Information

No publications provided

Responsible Party:	Acucela Inc.
ClinicalTrials.gov Identifier:	NCT01027013 History of Changes
Other Study ID Numbers:	ACU-RED-203
Study First Received:	December 4, 2009
Last Updated:	January 9, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Dry Eye Syndromes
Keratoconjunctivitis Sicca
Keratoconjunctivitis
Lacrimal Apparatus Diseases
Eye Diseases
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Tetrahydrozoline
Rebamipide
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents

Therapeutic Uses
Pharmacologic Actions
Respiratory System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012