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

March 1, 2023 updated by: iRenix Medical, Inc.

Randomized, Controlled, Double-Masked Study to Evaluate the Efficacy of IRX-101 in Reducing Post-Intravitreal 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78240
        • Recruiting
        • R. Gary Lane, II MD
        • Contact:
          • Francisco Angueira
          • Phone Number: 800-833-5921

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Immediately following intraviteral injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

iRenix Medical, Inc.

Investigators

  • Study Chair: Stephen Smith, MD, Founder

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 22, 2023

Primary Completion (Anticipated)

June 30, 2024

Study Completion (Anticipated)

August 30, 2024

Study Registration Dates

First Submitted

February 17, 2023

First Submitted That Met QC Criteria

February 28, 2023

First Posted (Actual)

March 1, 2023

Study Record Updates

Last Update Posted (Estimate)

March 3, 2023

Last Update Submitted That Met QC Criteria

March 1, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRX-2022-001

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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