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

This study has been completed.
Sponsor:
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Acucela Inc.
ClinicalTrials.gov Identifier:
NCT01057147
First received: January 25, 2010
Last updated: January 9, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


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

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 in Clearing of Fluorescein Staining of the Central Cornea in Subjects With Keratoconjunctivitis Sicca (Dry Eye)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Acucela Inc.:

Primary Outcome Measures:
  • Central corneal clearing as measured by fluorescein staining [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

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

Enrollment: 116
Study Start Date: February 2010
Study Completion Date: February 2011
Primary Completion Date: January 2011 (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
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01057147

Locations
United States, Arizona
East Valley Ophthalmology
Mesa, Arizona, United States, 85206
Cornea Consultants of Arizona
Phoenix, Arizona, United States, 85032
Arizona Center for Clinical Trials, LLC
Phoenix, Arizona, United States, 85003
United States, California
Macy Eye Center
Los Angeles, California, United States, 90048
United States, Colorado
Corneal Consultants of Colorado
Littleton, Colorado, United States, 80120
Specialty Eye Care
Parker, Colorado, United States, 80134
United States, Florida
Cohen Laser and Vision Center
Boca Raton, Florida, United States, 33431
Florida Eye Microsurgical Institute, Inc.
Boynton Beach, Florida, United States, 33426
Med Eye Associates
Miami, Florida, United States, 33143
United States, Kentucky
George R. John, 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, Missouri
Ophthalmology Associates
St. Louis, Missouri, United States, 63131
United States, Nevada
Avista Eye Center
Las Vegas, Nevada, United States, 89131
Nevada Eye Care Professionals
Las Vegas, Nevada, United States, 89119
United States, New York
New York Ophthalmology, PC
Manhasset, New York, United States, 11030
United States, North Carolina
Mundorf Eye Center
Charlotte, North Carolina, United States, 28204
United States, South Dakota
Black Hills Regional Eye Institute
Rapid City, South Dakota, United States, 57701
United States, Texas
The Cataract & Glaucoma Center
El Paso, Texas, United States, 79902
Sponsors and Collaborators
Acucela Inc.
Otsuka Pharmaceutical Co., Ltd.
Investigators
Study Director: Ryo Kubota, MD, PhD Acucela Inc.
  More Information

No publications provided

Responsible Party: Acucela Inc.
ClinicalTrials.gov Identifier: NCT01057147     History of Changes
Other Study ID Numbers: ACU-RED-204
Study First Received: January 25, 2010
Last Updated: January 9, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus 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 May 21, 2013