SteRilizing Eye SoLution to ImprovE Patient ComFort (RELIEF)

Phase 2

Recruiting

• Conditions: Retinal Disease
• Interventions: Drug: IRX-101; Drug: Providone-Iodine

• Registration Number: NCT05747430
• Lead Sponsor: iRenix Medical, Inc.

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-17
• Study First Submitted QC: 2023-02-17
• Study Start: 2023-02-22
• Study First Posted: 2023-02-28
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-09
• Last Update Posted: 2023-06-13
• Primary Completion: 2024-06-30
• Study Completion: 2024-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IRX-101	IRX-101	Subjects randomized to IRX-101 will receive the investigational product, IRX-101.
5% Povidone-iodine	Providone-Iodine	Subjects randomized to this arm will receive the standard of care, Providone-iodine, at a concentration of 5%.

Primary Outcome Measures

Name	Time	Method
Safety of new drug	1-hour and 1-week post-treatment	Safety will be measured via slit lamp and fundoscopic examinations

Secondary Outcome Measures

Name	Time	Method
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
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)

Trial Locations

Locations (1)

Edward Wood, MD; 🇺🇸 Round Rock, Texas, United States