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A Phase 2, Factorial-Designed, Randomized, Double-Blind, Placebo-Controlled, Parallel- Cohort Study to Evaluate Efficacy and Safety of MELT-300 and the Contribution of Midazolam and Ketamine Components to Sedation and Intraoperative Ocular Analgesia in Subjects Undergoing Cataract Extraction With Lens Replacement (CELR)

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Trial Profile

A Phase 2, Factorial-Designed, Randomized, Double-Blind, Placebo-Controlled, Parallel- Cohort Study to Evaluate Efficacy and Safety of MELT-300 and the Contribution of Midazolam and Ketamine Components to Sedation and Intraoperative Ocular Analgesia in Subjects Undergoing Cataract Extraction With Lens Replacement (CELR)

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 06 Dec 2023

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At a glance

  • Drugs Ketamine (Primary) ; Ketamine+midazolam (Primary) ; Midazolam (Primary)
  • Indications Sedation
  • Focus Registrational; Therapeutic Use
  • Sponsors Melt Pharmaceuticals

    • Most Recent Events

    • 21 Dec 2022 According to a Melt Pharmaceuticals media release, the company intends to request a meeting with the U.S. Food and Drug Administration (FDA) to discuss the results of this study and the continued clinical development of MELT-300.
    • 21 Dec 2022 Primary endpoint (Percentage of Participants with Success for Procedural Sedation by Using Ramsay Sedation Scale (RSS) Score) has been met, according to a Melt Pharmaceuticals media release.
    • 21 Dec 2022 Topline results published in the Melt Pharmaceuticals Media Release.

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