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

iRenix Medical, Inc. (Industry)
Overall Status
Recruiting ID

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Anticipated Enrollment :
240 participants
Intervention Model:
Parallel Assignment
Intervention Model Description:
Subjects will be randomized to IRX-101 or Providone-IodineSubjects will be randomized to IRX-101 or Providone-Iodine
Double (Participant, Investigator)
Masking Description:
Treatment assignment will be unknown (or masked) to the study subjects, the evaluating physician, the Sponsor and its agents (with the exception of personnel performing randomization, unmasked drug accountability study monitors, and corporate compliance staff). The treating physician will be unmasked.
Primary Purpose:
Official Title:
Randomized, Controlled, Double-Masked Study to Evaluate the Efficacy of IRX-101 in Reducing Post-Intravitreal Pain and Corneal Epitheliopathy
Anticipated Study Start Date :
Feb 22, 2023
Anticipated Primary Completion Date :
Jun 30, 2024
Anticipated Study Completion Date :
Aug 30, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Assessment of post-intravitreal injection eye pain [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 Outcome Measures

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

Eligibility Criteria


Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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

Contacts and Locations


Site City State Country Postal Code
1 R. Gary Lane, II MD San Antonio Texas United States 78240

Sponsors and Collaborators

  • iRenix Medical, Inc.


  • Study Chair: Stephen Smith, MD, Founder

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
iRenix Medical, Inc. Identifier:
Other Study ID Numbers:
  • IRX-2022-001
First Posted:
Mar 1, 2023
Last Update Posted:
Mar 3, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 3, 2023