SteRilizing Eye SoLution to ImprovE Patient ComFort (RELIEF)

Description

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

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Study Overview

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Study Details

Study 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).

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

SteRilizing Eye SoLution to ImprovE Patient ComFort (RELIEF)

Condition
Retinal Disease
Intervention / Treatment

-

Contacts and Locations

Round Rock

Edward Wood, MD, Round Rock, Texas, United States, 78681

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

iRenix Medical, Inc.,

Stephen Smith, MD, STUDY_CHAIR, Founder

Study Record Dates

2024-08-30