Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-3 (NCT03937882) | Clinical Trial Compass
CompletedPhase 3
Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-3
United States700 participantsStarted 2019-05-24
Plain-language summary
The objective of this study is to compare the safety and efficacy of RGN-259 Ophthalmic Solution 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 an uncontrolled systemic disease;
* Be a woman who is pregnant, nursing or planning a pregnancy
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.
1Since ARISE-3 was a Phase 3 trial for RGN-259 eye drops, meaning it was designed to confirm both safety and effectiveness — has this trial led to any FDA approval or published results I can review with you?
2This trial measured corneal staining as a key outcome, which reflects actual surface damage to the eye — based on my current corneal health, is that the kind of improvement I should be prioritizing in my treatment?
3The trial also tracked ocular discomfort on a 0-to-5 scale, so it was measuring symptom relief — how does the level of symptom relief seen in this study compare to what I might expect from standard dry eye treatments already available to me?
4Since this trial is now completed, is RGN-259 something I could potentially access today, or would I need to wait for it to go through additional regulatory steps before it becomes a real option?
5Given that this was studying a specific ophthalmic solution for dry eye, are there other treatments or eye drops my care team would recommend trying first before considering a newer investigational therapy like this one?
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.