Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome : ARISE-2 (NCT02974907) | Clinical Trial Compass
CompletedPhase 3
Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome : ARISE-2
United States601 participantsStarted 2016-11
Plain-language summary
The objective of this study is to compare the safety and efficacy of RGN-259 Ophthalmic Solutions to placebo for the treatment of the signs and symptoms of 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:
* Be at least 18 years of age;
* Provide written informed consent;
* Have a subject reported history of dry eye for at least 6 months
* Have a history of use or desire to use eye drops for dry eye symptoms within 6 months
Exclusion Criteria:
* Have any clinically significant slit-lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters;
* Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;
* Have ab uncontrolled systemic disease:
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 tested RGN-259 eye drops for dry eye syndrome and measured both how comfortable the eyes felt and whether the cornea showed less staining — since it's a completed Phase 3 study, has enough safety and effectiveness data been published that you can tell me what the results showed?
2The trial tracked corneal fluorescein staining as a key outcome, which measures actual surface damage to the eye — based on those results, how does RGN-259 compare to the dry eye treatments you might already recommend for me, like cyclosporine or lifitegrast drops?
3Since this is a completed Phase 3 trial, meaning it was specifically designed to test whether the treatment works and is safe in a larger group of people, do you think the evidence is strong enough to consider RGN-259 as a real option for my situation, or are there still gaps in the data?
4One of the main things this study measured was ocular discomfort — given my specific dry eye symptoms, would a treatment targeting the kind of discomfort this trial focused on actually address what I'm experiencing day to day?
5Before thinking about any newer option like RGN-259, should I first try or exhaust the standard treatments that are already approved, and what would that treatment path look like for me?
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.