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

Retinal Disease Clinical Trial

— COMFORT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05750589
• Other study ID #: IRX-2022-001
• Status: Recruiting
• Phase: Phase 3
• Start date: February 22, 2023
• Est. completion date: August 30, 2024

Study information

• Verified date: March 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• 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	R. Gary Lane, II MD	San Antonio	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	Assessment of post-intravitreal injection eye pain	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	Change in post-IVT corneal epitheliopathy as evaluated by corneal fluorescein staining scores	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