MELT-300 for Sedation in Cataract Surgery
Trial Summary
What is the purpose of this trial?
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.
Eligibility Criteria
Adults over 18 needing cataract surgery can join this trial. They must understand and follow the study's rules, avoid alcohol before surgery, and women must not be pregnant or use reliable birth control. People with certain health issues or taking specific drugs may not qualify.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Preoperative
Participants are admitted to the study unit and randomized to receive study medication 30 minutes before planned surgery
Intraoperative
Efficacy and safety assessments are performed during the surgery
Postoperative
Safety assessments are performed immediately after surgery and on Day 3 post dose
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- MELT-300
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Who Is Running the Clinical Trial?
Melt Pharmaceuticals
Lead Sponsor
Pharmalex
Collaborator
Evolution Research Group
Collaborator
MedTrials Incorporated
Collaborator
Catalent
Industry Sponsor