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

This study has been completed.
Sponsor:
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Acucela Inc.
ClinicalTrials.gov Identifier:
NCT01027013
First received: December 4, 2009
Last updated: January 9, 2012
Last verified: January 2012
  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 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 for the Treatment of Keratoconjunctivitis Sicca (Dry Eye)

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Ophthalmic Solutions
Rebamipide
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 29, 2014