SteRilizing Eye SoLution to ImprovE Patient ComFort (RELIEF) (RELIEF)

Randomized, Controlled, Double-Masked Study to Evaluate the Efficacy of IRX-101 in Reducing Post-Intravitreal Injection Pain and Corneal Epitheliopathy

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).

Study Overview

• Status: Completed
• Conditions: Retinal Disease
• Intervention / Treatment: Drug: IRX-101; Drug: Providone-Iodine

• Study Type: Interventional
• Enrollment (Actual): 155
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Greenwich, Connecticut, United States, 06830
      • Coastal Eye Surgeons, LLC
  • Mississippi
    • Madison, Mississippi, United States, 39110
      • Mississippi Retina Associates
  • Pennsylvania
    • Erie, Pennsylvania, United States, 16507
      • Erie Retina Research, LLC
  • South Carolina
    • Ladson, South Carolina, United States, 29456
      • Charleston Neuroscience Institute
  • Texas
    • Katy, Texas, United States, 77494
      • Retina Consultants of Texas
    • Round Rock, Texas, United States, 78681
      • Edward Wood, MD
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Retina Associates of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Capable of giving informed consent
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, ≥ 18 years of age and receiving intravitreal anti-VEGF injections in one or both eyes

Exclusion Criteria:

1. Current or past diagnosis of endophthalmitis
2. Current diagnosis of uveitis
3. Monocular patients (vision 20/100 or worse in one eye) who are receiving injections in the better seeing eye
4. Current use of viscous lidocaine products for ocular anesthesia prior to IVT
5. Currently receiving intravitreal steroid injections
6. Concurrent participation in another clinical trial
7. Females who are pregnant, planning to become pregnant or lactating

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IRX-101; Subjects randomized to IRX-101 will receive the investigational product, IRX-101.	Drug: IRX-101; IRX-101 is a novel ocular anti-septic
Active Comparator: 5% Povidone-iodine; Subjects randomized to this arm will receive the standard of care, Providone-iodine, at a concentration of 5%.	Drug: Providone-Iodine; 5% Providone-Iodine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of new drug	Safety will be measured via slit lamp and fundoscopic examinations	1-hour and 1-week post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-reported post-injection pain scores	Compare mean patient-reported post-injection pain scores 1-hour post-administration; pain will be assessed using the visual analog pain scale, a validated patient-reported outcome measure (questionnaire) for assessing patient's subjective pain and discomfort	1-hour post-administration
Mean corneal fluorescein staining scores	Compare mean corneal fluorescein staining scores obtained after IVT in the IRX-101 and standard of care groups; corneal staining will be obtained using the validated Oxford Corneal Staining scale of 0 (no staining) to 5 (maximal staining)	Immediately following intraviteral injection

Collaborators and Investigators

• Sponsor: iRenix Medical, Inc.
• Investigators: Study Chair: Stephen Smith, MD, Founder

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2023
• Primary Completion (Actual): March 6, 2025
• Study Completion (Actual): March 31, 2026

Study Registration Dates

• First Submitted: February 17, 2023
• First Submitted That Met QC Criteria: February 17, 2023
• First Posted (Actual): February 28, 2023

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases
• Other Study ID Numbers: IRX-2022-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No