SteRilizing Eye SoLution to ImprovE Patient ComFort (RELIEF)

NCT ID: NCT05747430

Last Updated: 2023-06-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-22
• Study Completion Date: 2024-08-30

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).

Conditions

Retinal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

IRX-101

Subjects randomized to IRX-101 will receive the investigational product, IRX-101.

Group Type: EXPERIMENTAL

IRX-101

Intervention Type: DRUG

IRX-101 is a novel ocular anti-septic

5% Povidone-iodine

Subjects randomized to this arm will receive the standard of care, Providone-iodine, at a concentration of 5%.

Group Type: ACTIVE_COMPARATOR

Providone-Iodine

Intervention Type: DRUG

5% Providone-Iodine

Interventions

IRX-101

IRX-101 is a novel ocular anti-septic

Intervention Type: DRUG

Providone-Iodine

5% Providone-Iodine

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

iRenix Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen Smith, MD

Role: STUDY_CHAIR

Founder

Locations

Edward Wood, MD

Round Rock, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Stephen Smith, MD

Role: CONTACT

stephen@irenix.com

650-785-1316

Facility Contacts

Daniel Dixon

Role: primary

512-451-0103

Other Identifiers

IRX-2022-002

Identifier Type: -

Identifier Source: org_study_id