SteRilizing Eye SoLution to ImprovE Patient ComFort (RELIEF)
United States155 participantsStarted 2023-02-22
Plain-language summary
This is a randomized, double-masked study to evaluate the tolerability and safety of IRX-101 versus 5% povidone-iodine (PI) in subjects receiving intravitreal anti-VEGF injections. The study will be conducted in up to 15 centers in the United States (US).
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
. Capable of giving informed consent
. Stated willingness to comply with all study procedures and availability for the duration of the study
. Male or female, ≥ 18 years of age and receiving intravitreal anti-VEGF injections in one or both eyes
Exclusion criteria
. Current or past diagnosis of endophthalmitis
. Current diagnosis of uveitis
. Monocular patients (vision 20/100 or worse in one eye) who are receiving injections in the better seeing eye
. Current use of viscous lidocaine products for ocular anesthesia prior to IVT
. Currently receiving intravitreal steroid injections
. Concurrent participation in another clinical trial
. Females who are pregnant, planning to become pregnant or lactating
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 was testing a sterilizing eye solution for retinal disease — since it was a Phase 2 study focused mainly on safety, what do we actually know so far about whether it was found to be safe, and are there any results I could review with you?
2Because this is a Phase 2 trial that has already completed, does that mean there's a next phase being planned, and would it be worth waiting to see if a larger trial opens up before considering this approach?
3How does this eye solution compare to whatever standard treatments already exist for my specific retinal condition — is there a reason to consider something newer that's still being studied over what's already approved?
4Since the trial measured safety as its main goal rather than how well the treatment works, what would we still not know about its effectiveness even if the safety results looked good?
5Are there any risks specific to using a sterilizing solution directly related to the eye that I should discuss with you, especially given that this was still in early-phase testing when the study ran?
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.