MELT-300 for Sedation in Cataract Surgery

Recruiting in Palo Alto (17 mi)

+11 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Melt Pharmaceuticals

Pivotal Trial (Near Approval)

Prior Safety Data

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

I am 18 years old or older.

I can avoid drinking alcohol 24 hours before the study starts.

I am scheduled for cataract surgery with lens replacement under local anesthesia.

+4 more

Participant Groups

The trial tests MELT-300's effectiveness for sedation during cataract surgery compared to a placebo and midazolam alone. It checks how quickly it works and its safety by monitoring participants before, during, after surgery on Day 1, and again on Day 3.

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: MELT-300 sublingual tabletExperimental Treatment1 Intervention

Participants will receive a single dose of MELT-300 sublingual, tablet containing 3 mg of midazolam and 50 mg of ketamine.

Group II: Midalozam sublingual tabletActive Control1 Intervention

Participants will receive a single dose of midazolam 3 mg sublingual tablet.

Group III: Placebo sublingual tabletPlacebo Group1 Intervention

Participants will receive a single dose of a matching placebo sublingual tablet.