A 1-Year Study in Multiple Clinics Testing Rebamipide Eye Drops for Dry Eye Compared With a Placebo (NCT00201981) | Clinical Trial Compass
CompletedPhase 3
A 1-Year Study in Multiple Clinics Testing Rebamipide Eye Drops for Dry Eye Compared With a Placebo
United States755 participantsStarted 2004-05-01
Plain-language summary
The purpose of this study is to determine the potential safety and effectiveness of rebamipide eye drops, an investigational eye drop being developed for the treatment of keratoconjunctivitis sicca (dry eye).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* must have symptoms of dry eye for a minimum of 6 months
* must be able to sign and date an informed consent
Exclusion Criteria:
* presence of anterior segment disease
* glaucoma or ocular hypertension
* using Restasis
* use of topically instilled ocular medications during study
* use of contact lenses
* history of ocular surgery within 12 months
* females who are pregnant, breast feeding, or child-bearing potential and not willing to remain abstinent or use contraception
* presence of Stevens-Johnson syndrome
* any anticipated change in medication through-out study
* concurrent involvement in another study or previous receipt of this drug
* cannot be safely be weaned off of ocular medications
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compared rebamipide eye drops to a placebo over 1 year, measuring corneal staining and eye discomfort at 12 weeks — what does my own corneal staining look like right now, and would those kinds of measurements help guide my treatment?
2Since this was a Phase 3 trial that has already completed, has rebamipide eye drops been approved or made available based on its results, and would it be an option worth considering for my dry eye condition?
3The trial focused on a specific type of dry eye called keratoconjunctivitis sicca — do I have that diagnosis, and does that affect whether the findings from this study would even be relevant to my situation?
4The study used a placebo comparison, meaning some participants received no active treatment for up to a year — compared to that, how do currently available dry eye treatments I haven't tried yet stack up, and should we explore those first?
5Since the trial measured both a physical sign (corneal staining) and how patients felt (eye discomfort severity), can you help me understand which of those matters more in my case when deciding how well a treatment is actually working?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
fluorescein corneal staining (FCS) total score at week 12 and the average primary ocular discomfort (POD) severity score at week 12
Timeframe: 12 week and 26 week
Trial details
NCT IDNCT00201981
SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.