Randomized, Controlled, Double-Masked Study to Evaluate the Efficacy of IRX-101 in Reducing Post-Intravitreal Injection Pain and Corneal Epitheliopathy
Latest Information Update: 15 Jun 2023
At a glance
- Drugs IRX-101 (Primary) ; Povidone iodine
- Indications Corneal disorders; Ocular pain
- Focus Adverse reactions; Registrational
- Acronyms RELIEF
- Sponsors iRenix Medical
- 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