Overview

EffiCacy, Safety and ToLErability of a Novel Ocular ANtiseptic for Ocular Use (CLEAN)

Status:
Recruiting

Trial end date:
2024-01-31

Target enrollment:
0

Participant gender:
All

Summary

This is a randomized, double-masked, multicenter, study to evaluate the efficacy, safety, and tolerability of IRX-101 versus 5% povidone-iodine (PI) in subjects receiving intravitreal anti-VEGF injections. The study will be conducted in up to 30 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. Current use of viscous lidocaine products for ocular anesthesia prior to IVT

4. Currently receiving intravitreal steroid injections

5. Concurrent participation in another clinical trial