A Study to Evaluate Efficacy and Safety of MELT-300 for Procedural Sedation in Subjects Undergoing Cataract Extraction With Lens Replacement (CELR) - Trial NCT06383273
Access comprehensive clinical trial information for NCT06383273 through Pure Global AI's free database. This Phase 3 trial is sponsored by Melt Pharmaceuticals and is currently Recruiting. The study focuses on Cataract. Target enrollment is 486 participants.
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Study Focus
Sponsor & Location
Melt Pharmaceuticals
Timeline & Enrollment
Phase 3
May 01, 2024
Jan 01, 2025
Primary Outcome
Percentage of Participants Achieving Successful Procedural Sedation
Summary
The goal of this clinical trial is to learn if MELT-300 works on procedural sedation in adult
 participants undergoing cataract extraction with lens replacement (CELR). It will also learn
 about the safety of MELT-300. Researchers will compare MELT-300 to a placebo (a look-alike
 substance that contains no drug) to see if MELT-300 works on procedural sedation in adult
 participants undergoing CELR. Researchers will also include a comparator SL midazolam to
 confirm the benefit of inclusion of ketamine in the combined drug product.
 
 The main questions it aims to answer are:
 
 1. Does MELT-300 is effective in comparison to placebo on procedural sedation for cataract
 surgery?
 
 2. To determine the effectiveness of MELT-300 compared with midazolam on procedural
 sedation (to determine the contribution of ketamine component and inform the risk of
 ketamine in MELT-300)
 
 3. To determine the time to achieve preoperative target sedation level with MELT-300
 
 4. What medical problems do participants have when taking MELT-300 vs placebo
 
 Eligible participants will admitted to the study unit on Day 1. Participants will be
 randomized prior to surgery 4:1:1 to
 
 1. MELT-300 (i.e. 1 MELT-300 sublingual tablet which contains 3 mg midazolam and 50 mg of
 ketamine)
 
 2. Midazolam (i.e. 1 matching midazolam sublingual tablet which contains 3 mg midazolam)
 
 3. Placebo (i.e. 1 matching placebo sublingual tablet)
 
 Participants will receive study medication 30 (± 5) minutes, without food or water, before
 planned surgery start (defined as instillation of topical ocular anesthetic gel [i.e.. 3
 drops of chloroprocaine hydrochloride ophthalmic gel)].
 
 The effectiveness of MELT-300 will be performed after study medication is administered before
 surgery, in the course of surgery, and postoperative on Day 1 (end of surgery defined as just
 prior to drape removal). The safety of MELT-300 will be performed at baseline, in the course
 of surgery, postoperatively on Day 1, and on Day 3 ± 1 day post dose of study medication.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06383273
Non-Device Trial