SteRilizing Eye SoLution to ImprovE Patient ComFort (RELIEF)

NCT05747430 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: IRX-2022-002
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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. The study will be conducted in up to 15 centers in the United States (US).

Conditions

Retinal Disease

Outcome Measures

Primary Outcomes (1)

• Safety of new drug

  Safety will be measured via slit lamp and fundoscopic examinations

  1-hour and 1-week post-treatment

Secondary Outcomes (2)

• Mean corneal fluorescein staining scores

  Immediately following intraviteral injection

• Patient-reported post-injection pain scores

  1-hour post-administration

Study Arms (2)

IRX-101

EXPERIMENTAL

Subjects randomized to IRX-101 will receive the investigational product, IRX-101.

Drug: IRX-101

5% Povidone-iodine

ACTIVE COMPARATOR

Subjects randomized to this arm will receive the standard of care, Providone-iodine, at a concentration of 5%.

Drug: Providone-Iodine

Interventions

IRX-101 DRUG

IRX-101 is a novel ocular anti-septic

IRX-101

Providone-Iodine DRUG

5% Providone-Iodine

5% Povidone-iodine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• iRenix Medical, Inc.: lead

Study Sites (1)

Edward Wood, MD

Round Rock, Texas, 78681, United States

RECRUITING

MeSH Terms

Conditions

Retinal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Stephen Smith, MD

  Founder

  STUDY CHAIR

Central Study Contacts

Stephen Smith, MD

CONTACT

650-785-1316; stephen@irenix.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized to IRX-101 or Providone-Iodine

Study Record Dates

• First Submitted: February 17, 2023
• First Posted: February 28, 2023
• Study Start: February 22, 2023
• Primary Completion: June 30, 2024
• Study Completion: August 30, 2024
• Last Updated: June 13, 2023

Record last verified: 2023-06

Locations

US (1)