CompletedPhase 2

SteRilizing Eye SoLution to ImprovE Patient ComFort (RELIEF)

United States155 participantsStarted 2023-02-22

Plain-language 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).

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
✕. Monocular patients (vision 20/100 or worse in one eye) who are receiving injections in the better seeing eye
✕. Current use of viscous lidocaine products for ocular anesthesia prior to IVT
✕. Currently receiving intravitreal steroid injections
✕. Concurrent participation in another clinical trial
✕. Females who are pregnant, planning to become pregnant or lactating

What they're measuring

Safety of new drug

Timeframe: 1-hour and 1-week post-treatment

Trial details

NCT IDNCT05747430

SponsoriRenix Medical, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-03-06

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