MELT-300 for Sedation During Cataract Surgery
This study is testing a new sublingual (under the tongue) tablet called MELT-300 for sedation during cataract extraction with lens replacement (CELR) surgery. MELT-300 contains two medications: midazolam and ketamine. Researchers want to see if MELT-300 is effective and safe for sedation compared to a placebo (a tablet with no medicine) and also compared to midazolam alone. You may be able to join if you are between 18 and 65 years old and are scheduled for a cataract surgery on one eye. The main goal is to see how many participants achieve successful sedation during their surgery.
- Study design
- This is a Phase 3, randomized, double-blind study involving about 528 participants. Participants will be randomly assigned to receive MELT-300, midazolam, or a placebo.
- What's involved
- You will receive a sublingual tablet 30 minutes before your surgery. Efficacy will be assessed before, during, and after surgery on Day 1.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your sedation will be assessed on Day 1, before, during, and after surgery.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study to Evaluate Efficacy and Safety of MELT-300 for Procedural Sedation in Subjects Undergoing Cataract Extraction With Lens Replacement (CELR)
At a glance
Conditions
Where it's being run
12 sites across 11 statesWho to contact
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What this trial measures
- Percentage of Participants Achieving Successful Procedural SedationPreoperative (Day 1), Intraoperative (Day 1), and Postoperative (Day 1)
Successful procedural sedation is defined as achieving target sedation level (Ramsay Sedation Scale \[RSS\] level 2 or 3) by the start of surgery without need for rescue sedation medication, no requirement for intraoperative sedation medication, and able to complete the surgery (i.e. procedural sedation responder). The Ramsay Sedation Scale (RSS) was the first scale to be defined for the sedated participants and was designed as a test of arousability. The Ramsay Scale provides three levels of 'awake' states (score 1-3) and three levels of 'asleep' states (score 4-6). A score of 2 (participant is cooperative, orientated, and tranquil) best fits an optimum sedation level based on the criteria of calm, comfortable, communicative, and cooperative participants.