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Randomized, Controlled, Double-Masked Study to Evaluate the Efficacy of IRX-101 in Reducing Post-Intravitreal Injection Pain and Corneal Epitheliopathy

Trial Profile

Randomized, Controlled, Double-Masked Study to Evaluate the Efficacy of IRX-101 in Reducing Post-Intravitreal Injection Pain and Corneal Epitheliopathy

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 15 Jun 2023

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At a glance

  • Drugs IRX-101 (Primary) ; Povidone iodine
  • Indications Corneal disorders; Ocular pain
  • Focus Adverse reactions; Registrational
  • Acronyms RELIEF
  • Sponsors iRenix Medical
  • Most Recent Events

    • 09 Jun 2023 Phase of the trial is changed form phase 3 to phase 2. Primary efficacy end-point "Patient-reported post-injection pain scores" is replaced by primary safety end-point- "Safety of new drug", thus changing trial focus from "TU" to "AR". Planned patient number is decreased.
    • 09 Jun 2023 Planned number of patients changed from 240 to 75.
    • 02 Mar 2023 New trial record

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