TerminatedPhase 3

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

Stopped: Adverse event

United States5 participantsStarted 2021-11-15

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

Incidence of infectious endophthalmitis after topical use of IRX-101 combined with IVT

Timeframe: 2 hours post-injection

Trial details

NCT IDNCT05127525

SponsoriRenix Medical, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-01-31

View on ClinicalTrials.gov More Diabetic Macular Edema trials