Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06383273 | A Study to Evaluate Efficacy and Safety of MELT-300 for Procedural Sedation in Subjects Undergoing Cataract Extraction With Lens Replacement (CELR) | PHASE3 | RECRUITING | 528 | — | — | May 1, 2024 | Jan 1, 2025 | Aug 2, 2024 | 12 | United States |
| 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) | PHASE2 | COMPLETED | 338 | — | — | Jul 20, 2021 | Nov 3, 2022 | Dec 19, 2022 | 3 | United States |
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.
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. Ramsay Sedation Scale 1. =Participant is anxious and agitated or restless, or both 2. =Participant is cooperative, oriented, and tranquil 3. =Participant responds to commands only 4. =Participant exhibits brisk response to a light glabellar tap or loud auditory stimulus 5. =Participant exhibits a sluggish response to a light glabellar tap or loud auditory stimulus 6. =Participants exhibits no response RSS score will be assessed pre-operatively, intra-operatively, and post-operatively on Day 1
The Numeric Pain Rating Scale (NPRS) is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
| Arm | Type | Description |
|---|---|---|
| MELT-300 sublingual tablet | EXPERIMENTAL | Participants will receive a single dose of MELT-300 sublingual, tablet containing 3 mg of midazolam and 50 mg of ketamine. |
| Midalozam sublingual tablet | ACTIVE_COMPARATOR | Participants will receive a single dose of midazolam 3 mg sublingual tablet. |
| Placebo sublingual tablet | PLACEBO_COMPARATOR | Participants will receive a single dose of a matching placebo sublingual tablet. |
| MELT-300 | ACTIVE_COMPARATOR | Participants will receive a single dose of MELT-300 sublingual, rapidly dissolving tablet containing 3 mg of midazolam and 50 mg of ketamine. |
| Midazolam alone | ACTIVE_COMPARATOR | Participants will receive a single dose of midazolam 3 mg sublingual tablet. |
| Ketamine alone | ACTIVE_COMPARATOR | Participants will receive a single dose of ketamine 50 mg sublingual tablet. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive a single dose of a matching placebo sublingual tablet. |
| Name | Type | Description |
|---|---|---|
| MELT-300 sublingual tablet | DRUG | Each dose of MELT-300 will be provided as a single sublingual tablet, containing 3 mg midazolam and 50 mg ketamine. Participants will receive 1 sublingual tablet of study medication 30 (± 5) minutes prior to planned surgery start, without food or water. |
| Midalozam sublingual tablet | DRUG | Each dose of midazolam will be provided as a single sublingual tablet, containing 3 mg midazolam. Participants will receive 1 sublingual tablet of study medication 30 (± 5) minutes prior to planned surgery start, without food or water. |
| Placebo sublingual tablet | DRUG | Each dose of placebo will be provided as a matching sublingual tablet, containing placebo. Participants will receive 1 sublingual tablet of study medication 30 (± 5) minutes prior to planned surgery start, without food or water. |
| MELT-300 | DRUG | Sublingual tablet |
| Midazolam alone | DRUG | Sublingual tablet |
| Ketamine alone | DRUG | Sublingual tablet |
| Placebo | DRUG | Sublingual tablet |
Inclusion Criteria: Participants must meet all of the following in order to be enrolled into the study: 1. Males and females ≥ 18 years of age 2. Are to undergo unilateral primary CELR under topical anesthesia, with a phacoemulsification device and insertion of an intraocular lens (no restrictions...