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Not Yet Recruiting NCT05747430

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

Conditions: Retinal Disease

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Phase: PHASE3
Enrollment: 500
Sponsor: iRenix Medical, Inc.

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).

Eligibility Criteria

Inclusion Criteria:Capable of giving informed consentStated willingness to comply with all study procedures and availability for the duration of the studyMale or female, ≥ 18 years of age and receiving intravitreal anti-VEGF injections in one or both eyesExclusion Criteria:Current or past diagnosis of endophthalmitisCurrent diagnosis of uveitisMonocular patients (vision 20/100 or worse in one eye) who are receiving injections in the better seeing eyeCurrent use of viscous lidocaine products for ocular anesthesia prior to IVTCurrently receiving intravitreal steroid injectionsConcurrent participation in another clinical trialFemales who are pregnant, planning to become pregnant or lactating

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05747430). StuddyBuddy aggregates publicly available trial information.