SteRilizing Eye SoLution to ImprovE Patient ComFort (RELIEF)

Retinal Disease Clinical Trial

— RELIEF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05747430
• Other study ID #: IRX-2022-002
• Status: Recruiting
• Phase: Phase 2
• Start date: February 22, 2023
• Est. completion date: August 30, 2024

Study information

• Verified date: June 2023
• Source: iRenix Medical, Inc.
• Contact: Stephen Smith, MD
• Phone: 650-785-1316
• Email: stephen[@]irenix.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: August 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Retinal Disease
• Retinal Diseases

Intervention

Drug:
• IRX-101
IRX-101 is a novel ocular anti-septic
• Providone-Iodine
5% Providone-Iodine

Locations

Country	Name	City	State
United States	Edward Wood, MD	Round Rock	Texas

Sponsors (1)

Lead Sponsor	Collaborator
iRenix Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of new drug	Safety will be measured via slit lamp and fundoscopic examinations	1-hour and 1-week post-treatment
Secondary	Mean corneal fluorescein staining scores	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)	Immediately following intraviteral injection
Secondary	Patient-reported post-injection pain scores	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	1-hour post-administration