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Antiseptics for Eye Injection Comfort (RELIEF Trial)
Phase 2
Recruiting
Research Sponsored by iRenix Medical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-hour and 1-week post-treatment
Awards & highlights
RELIEF Trial Summary
This trial will compare the safety and tolerability of a new antiseptic (IRX-101) vs. standard antiseptic (PI) for eye injections in up to 15 US centers.
Who is the study for?
The RELIEF trial is for adults (18+) who are currently receiving eye injections for retinal disease and can consent to study procedures. It's not open to those with a history of severe eye infections, inflammation, poor vision in one eye getting treatment in the better eye, using certain anesthetics or steroids for the eyes, involved in other trials, or women who are pregnant or breastfeeding.Check my eligibility
What is being tested?
This study compares IRX-101 with a standard antiseptic solution called povidone-iodine (PI) used before anti-VEGF injections into the eye. Participants will be randomly assigned to either IRX-101 or PI groups without knowing which one they receive ('double-masked') across up to 15 US centers.See study design
What are the potential side effects?
While specific side effects of IRX-101 aren't detailed here, typical reactions might include discomfort at the injection site, allergic reactions to ingredients similar to iodine-based solutions like PI which may cause irritation or redness.
RELIEF Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ immediately following intraviteral injection
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately following intraviteral injection
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety of new drug
Secondary outcome measures
Mean corneal fluorescein staining scores
Patient-reported post-injection pain scores
RELIEF Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: IRX-101Experimental Treatment1 Intervention
Subjects randomized to IRX-101 will receive the investigational product, IRX-101.
Group II: 5% Povidone-iodineActive Control1 Intervention
Subjects randomized to this arm will receive the standard of care, Providone-iodine, at a concentration of 5%.
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Who is running the clinical trial?
iRenix Medical, Inc.Lead Sponsor
2 Previous Clinical Trials
245 Total Patients Enrolled
Stephen Smith, MDStudy ChairFounder
3 Previous Clinical Trials
305 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had or currently have an eye infection.I am currently getting steroid injections in my eye.I have poor vision in one eye and receive injections in my better eye.I am currently using viscous lidocaine for eye numbing before eye injections.I am 18 or older and get eye injections for my eye condition.I have been diagnosed with uveitis.I understand the study and can agree to participate.I am not pregnant, planning to become pregnant, or breastfeeding.
Research Study Groups:
This trial has the following groups:- Group 1: 5% Povidone-iodine
- Group 2: IRX-101
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the Food & Drug Administration sanctioned IRX-101 for clinical use?
"IRX-101's safety record is highly reliable, and thus it merited a 3 on our team at Power's scale of 1 to 3. This medication has been subject to data collection in multiple trials that suggest efficacy as well as numerous rounds of testing which point towards its security profile."
Answered by AI
Is this experiment currently recruiting participants?
"This clinical trial is open for recruitment, with the initial post date having been February 22nd 2023 and a recent edit on March 1st of the same year."
Answered by AI
How many research participants are currently engaging in this experiment?
"Indeed, the clinicaltrials.gov page for this study confirms that it is actively enlisting participants. The experiment was first posted on February 22nd 2023 and has been updated as recently as March 1st of the same year. 240 patients are being sought from a single research centre."
Answered by AI
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