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OpenTrials
Completed

NCT Number: NCT05747430

SteRilizing Eye SoLution to ImprovE Patient ComFort (RELIEF)

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).

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Key information

Conditions

Retinal Disease Eye Diseases Retinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Coastal Eye Surgeons, LLC, Greenwich, Connecticut, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IRX-101

Drug

IRX-101 is a novel ocular anti-septic

Providone-Iodine

Drug

5% Providone-Iodine

Primary outcomes

  1. Safety of new drug

    Time frame: 1-hour and 1-week post-treatment

    Safety will be measured via slit lamp and fundoscopic examinations

Secondary outcomes

  1. Mean corneal fluorescein staining scores

    Time frame: Immediately following intraviteral injection

    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)

  2. Patient-reported post-injection pain scores

    Time frame: 1-hour post-administration

    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

Sponsors and collaborators

Lead sponsor

iRenix Medical, Inc.

Industry

Registry information

Official study title

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

Acronym: RELIEF

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Feb 28, 2023
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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