drugset / Trial / NCT05133518
A Study of MELT-300 (Midazolam and Ketamine Sublingual Tablets) for Sedation and Intraoperative Ocular Analgesia in Participants Undergoing Cataract Extraction With Lens Replacement (CELR)
RandomizedParallel-groupQuadruple-blindPrevention
Summary
The primary purpose of the study is to evaluate the efficacy and safety of MELT-300 (Midazolam and Ketamine Sublingual Tablets) and the contribution of midazolam and ketamine components to sedation and during the surgery or ocular analgesia in participants undergoing cataract surgery with lens replacement.
Timeline
- Start
- 2021-07-20
- Primary completion
- 2022-10-26
- Completion
- 2022-11-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ketamine | Small molecule | 50 mg | Other |
| Comparator | Midazolam | Small molecule | 3 mg | Other |