Evaluate the Efficacy of IRX-101 in Reducing Post-Intravitreal Injection Pain and Corneal Epitheliopathy

• Status: Not yet recruiting
• Trial end date: 2024-08-30
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: iRenix Medical, Inc.

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