SteRilizing Eye SoLution to ImprovE Patient ComFort (RELIEF)

Sponsor

iRenix Medical, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05747430

Collaborator

(none)

240

Enrollment

Location

Arms

18.2

Anticipated Duration (Months)

13.2

Patients Per Site Per Month

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

Condition or Disease	Intervention/Treatment	Phase
Retinal Disease	Drug: IRX-101 Drug: Providone-Iodine	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

240 participants

Allocation:

Randomized

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

Masking:

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:

Treatment

Official Title:

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

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

Patient-reported post-injection pain scores [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

Secondary Outcome Measures

Mean corneal fluorescein staining scores [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Edward Wood, MD	Round Rock	Texas	United States	78681

Sponsors and Collaborators

iRenix Medical, Inc.

Investigators

Study Chair: Stephen Smith, MD, Founder

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

iRenix Medical, Inc.

ClinicalTrials.gov Identifier:

NCT05747430

Other Study ID Numbers:

IRX-2022-002

First Posted:

Feb 28, 2023

Last Update Posted:

Mar 3, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Retinal Diseases

Study Results

No Results Posted as of Mar 3, 2023