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NCT05133518 · ClinicalTrials.gov registry record · Phase 2
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)
A Phase 2 study of Cataract, sponsored by Melt Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 338
- Enrollment target
- 3
- Study locations
NCT05133518: Completed Phase 2 study of Cataract, sponsored by Melt Pharmaceuticals.
NCT05133518 is a Phase 2 study of Cataract that has completed, run by Melt Pharmaceuticals. The registered enrollment target is 338 participants, above the 224-participant average among 83 other Cataract trials with a reported enrollment target (51% higher). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05133518, a Phase 2 study of Cataract, has completed, sponsored by Melt Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 338 participants
- Enrollment target
- 3
- Study locations
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- DRUG Placebo
- DRUG MELT-300
- DRUG Midazolam alone
- DRUG Ketamine alone
Study Locations (3)
California
- Martel Eye Medical Group - Rancho Cordova
Florida
- Levenson Eye Associates - Jacksonville
North Dakota
- Vance Thompson Vision - West Fargo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 338 participants |
| Start Date | 2021-07-20 |
| Est. Completion | 2022-11-03 |
| Phase | Phase 2 |
What the finished NCT05133518 record still lists
NCT05133518 is an interventional study that assigns participants to a tested intervention. The registered 338 participants enrollment target is mid-sized for trials with a published cap, above the 224-participant average among 83 other Cataract trials with a reported enrollment target (51% higher).
The record links to 1 condition, with Cataract appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT05133518 reports a single indexed study location in California, Florida, North Dakota.
Frequently Asked Questions
What is clinical trial NCT05133518 about?
NCT05133518 is a clinical study titled "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)". 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 repla...
What is the current status of trial NCT05133518?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 338 participants. The study started on 2021-07-20. Estimated completion is 2022-11-03.
What conditions does trial NCT05133518 study?
This clinical trial studies the following conditions: Cataract.
What interventions are being tested in trial NCT05133518?
The interventions under investigation include: Placebo (DRUG), MELT-300 (DRUG), Midazolam alone (DRUG), Ketamine alone (DRUG).
Who is sponsoring clinical trial NCT05133518?
This trial is sponsored by Melt Pharmaceuticals, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05133518 being conducted?
This trial has 3 study locations across California, Florida, North Dakota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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338 15th of 83 higher than 69 of 83 other Cataract trials
participants (enrollment target), bucketed by value
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