Efficacy and Safety of Rebamipide in Subjects With Dry Eye Syndrome
A Phase 3 Study to Determine the Efficacy and Safety of Rebamipide in Subjects With Dry Eye Syndrome
1 other identifier
interventional
564
1 country
34
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of rebamipide ophthalmic suspension in subjects with dry eye syndrome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 28, 2012
CompletedFirst Posted
Study publicly available on registry
July 2, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedMay 7, 2014
April 1, 2014
1 year
June 28, 2012
April 17, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
Primary ocular sign: Fluorescein corneal staining total score
4 weeks
Primary ocular symptom: Worst ocular symptom severity score
4 weeks
Secondary Outcomes (2)
Fluorescein corneal staining total score
2 weeks
Worst ocular symptom severity score
2 weeks
Study Arms (2)
Placebo (vehicle)
PLACEBO COMPARATORRebamipide 2% ophthalmic suspension
EXPERIMENTALInterventions
Instill one drop into each eye 4 times a day for 4 weeks.
Eligibility Criteria
You may qualify if:
- History of dry eye-related ocular symptoms for at least 20 months.
- Meet protocol-defined criteria for corneal and conjunctival staining.
- Meet protocol-defined criteria for ocular discomfort.
You may not qualify if:
- Active anterior segment ocular disease other than dry eye syndrome.
- Inability to suspend the use of topical ophthalmic medications throughout the duration of the study.
- Inability to suspend the use of contact lenses for the duration of the study.
- Judged by the investigator to be ineligible for the study because of a past or concurrent systemic disease, or safety concerns.
- Received any other investigational product within 4 months before the screening visit.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kubota Vision Inc.lead
- Otsuka Pharmaceutical Co., Ltd.collaborator
Study Sites (34)
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Little Rock, Arkansas, United States
Unknown Facility
Artesia, California, United States
Unknown Facility
Glendale, California, United States
Unknown Facility
Inglewood, California, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
Wheat Ridge, Colorado, United States
Unknown Facility
Fort Myers, Florida, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
Plantation, Florida, United States
Unknown Facility
Stuart, Florida, United States
Unknown Facility
Tampa, Florida, United States
Unknown Facility
Morrow, Georgia, United States
Unknown Facility
Baton Rouge, Louisiana, United States
Unknown Facility
Lutherville, Maryland, United States
Unknown Facility
Kansas City, Missouri, United States
Unknown Facility
St Louis, Missouri, United States
Unknown Facility
Washington, Missouri, United States
Unknown Facility
Las Vegas, Nevada, United States
Unknown Facility
Princeton, New Jersey, United States
Unknown Facility
Rochester, New York, United States
Unknown Facility
Rockville Centre, New York, United States
Unknown Facility
Valley Stream, New York, United States
Unknown Facility
Wantagh, New York, United States
Unknown Facility
Ashville, North Carolina, United States
Unknown Facility
Charlotte, North Carolina, United States
Unknown Facility
Cleveland, Ohio, United States
Unknown Facility
Mason, Ohio, United States
Unknown Facility
Pittsburgh, Pennsylvania, United States
Unknown Facility
Chattanooga, Tennessee, United States
Unknown Facility
Memphis, Tennessee, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
Salt Lake City, Utah, United States
Unknown Facility
Norfolk, Virginia, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Acucela Medical Monitor
Kubota Vision Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2012
First Posted
July 2, 2012
Study Start
June 1, 2012
Primary Completion
June 1, 2013
Last Updated
May 7, 2014
Record last verified: 2014-04