SteRilizing Eye SoLution to ImprovE Patient ComFort (RELIEF)

iRenix Medical, Inc.155 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

155

Conditions

Retinal Disease

Interventions

IRX-101DRUG

IRX-101 is a novel ocular anti-septic

Providone-IodineDRUG

5% Providone-Iodine

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (7)

Coastal Eye Surgeons, LLC

Greenwich, Connecticut, United States

Mississippi Retina Associates

Madison, Mississippi, United States

Erie Retina Research, LLC

Erie, Pennsylvania, United States

Charleston Neuroscience Institute

Ladson, South Carolina, United States

Outcomes

Primary Outcomes

Safety of new drug

Safety will be measured via slit lamp and fundoscopic examinations

Time frame: 1-hour and 1-week post-treatment

Secondary Outcomes

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)

Time frame: Immediately following intraviteral injection

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

Time frame: 1-hour post-administration

Data from ClinicalTrials.gov

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