Efficacy and Safety of Rebamipide in Subjects With Dry Eye Syndrome
NCT ID: NCT01632137
Last Updated: 2014-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
564 participants
INTERVENTIONAL
2012-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Efficacy Study of Rebamipide 2% Ophthalmic Suspension in Patients With Dry Eye
NCT01027013
Safety and Efficacy Study of Rebamipide 2% Ophthalmic Suspension in Subjects With Dry Eye - Effects on Central Cornea
NCT01057147
Study of Rebamipide Eye Drops to Treat Dry Eye
NCT00201981
Study of Rebamipide Eye Drops to Treat Dry Eye
NCT00201955
A Study to Evaluate the Safety, Tolerability, and Efficacy of A197 in Subjects With Dry Eye Disease
NCT05238597
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo (vehicle)
Placebo (vehicle)
Instill one drop into each eye 4 times a day for 4 weeks.
Rebamipide 2% ophthalmic suspension
Rebamipide 2% ophthalmic suspension
Instill one drop into each eye 4 times a day for 4 weeks.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Rebamipide 2% ophthalmic suspension
Instill one drop into each eye 4 times a day for 4 weeks.
Placebo (vehicle)
Instill one drop into each eye 4 times a day for 4 weeks.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Meet protocol-defined criteria for corneal and conjunctival staining.
* Meet protocol-defined criteria for ocular discomfort.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Otsuka Pharmaceutical Co., Ltd.
INDUSTRY
Kubota Vision Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Acucela Medical Monitor
Role: STUDY_DIRECTOR
Kubota Vision Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Phoenix, Arizona, United States
Little Rock, Arkansas, United States
Artesia, California, United States
Glendale, California, United States
Inglewood, California, United States
San Diego, California, United States
Wheat Ridge, Colorado, United States
Fort Myers, Florida, United States
Miami, Florida, United States
Plantation, Florida, United States
Stuart, Florida, United States
Tampa, Florida, United States
Morrow, Georgia, United States
Baton Rouge, Louisiana, United States
Lutherville, Maryland, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Washington, Missouri, United States
Las Vegas, Nevada, United States
Princeton, New Jersey, United States
Rochester, New York, United States
Rockville Centre, New York, United States
Valley Stream, New York, United States
Wantagh, New York, United States
Ashville, North Carolina, United States
Charlotte, North Carolina, United States
Cleveland, Ohio, United States
Mason, Ohio, United States
Pittsburgh, Pennsylvania, United States
Chattanooga, Tennessee, United States
Memphis, Tennessee, United States
Houston, Texas, United States
Salt Lake City, Utah, United States
Norfolk, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ACU-RED-301
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.