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

Stopped early · Phase 3

Conditions studied: Diabetic Macular Edema, Branch Retinal Vein Occlusion, Glaucoma/Closed Angle Glaucoma

In brief

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).

Key facts

Study ID

NCT05127525

Run by

iRenix Medical, Inc.

People needed

5

Starts

2021-11-15

Expected to finish

2022-01-31

Last updated by the study team

2022-05-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Capable of giving informed consent
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, ≥ 18 years of age and receiving intravitreal anti-VEGF injections in one or both eyes

You may not qualify if…

• Current or past diagnosis of endophthalmitis
• Current diagnosis of uveitis
• Current use of viscous lidocaine products for ocular anesthesia prior to IVT
• Currently receiving intravitreal steroid injections
• Concurrent participation in another clinical trial

Where it is running

• Florida — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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