A Phase 3, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group, Multi-Center Study to Evaluate Efficacy and Safety of MELT-300 for Procedural Sedation in Subjects Undergoing Cataract Extraction With Lens Replacement (CELR)
Latest Information Update: 04 Dec 2025
At a glance
- Drugs Ketamine+midazolam (Primary) ; Midazolam
- Indications Sedation
- Focus Registrational; Therapeutic Use
- Acronyms LOUISE
- Sponsors Harrow; Melt Pharmaceuticals
Most Recent Events
- 18 Nov 2025 According to a Harrow media release, the Melt Pharmaceuticals has been acquired and merged into Harrow.
- 20 Nov 2024 According to a Melt Pharmaceuticals media release, The study was conducted at 13 clinical sites in the United States and enrolled over 530 patients.
- 20 Nov 2024 Status changed from recruiting to active, no longer recruiting, according to a Melt Pharmaceuticals Media Release.