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NCT Number: NCT05750589

Safety and Tolerability of IRX-101 in Patients Receiving Intravitreal Injections

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.

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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 3

Primary location

R. Gary Lane, II MD

San Antonio, Texas, 78240, United States

Location contact

Francisco Angueira

CONTACT

800-833-5921

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. Assessment of post-intravitreal injection eye pain

    Time frame: Demonstrate a reduction in mean 1-hr post-injection pain scores

    Demonstrate the superiority of IRX-101 compared to PI in terms of reducing patient-reported post-intravitreal injection eye pain; 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

Secondary outcomes

  1. Change in post-IVT corneal epitheliopathy as evaluated by corneal fluorescein staining scores

    Time frame: Immediately following intraviteral injection

    Demonstrate the superiority of IRX-101 compared to PI in terms of reducing corneal epitheliopathy / corneal fluorescein staining post-intravitreal injection; corneal staining will be obtained using validated Oxford Corneal Staining scale of 0 (no staining) to 5 (maximal corneal staining)

Study contacts

Contact information is provided by the study sponsor or research team.

Stephen Smith, MD

CONTACT

[email protected]

650-785-1316

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 Pain and Corneal Epitheliopathy

Acronym: COMFORT

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 1, 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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