Condition: Cataract · Sponsor: Melt Pharmaceuticals
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 su…
This description comes directly from the study's public registry record.
Giovanni DeCastro · 6157670074 · gdecastro@meltpharma.com
Larry Dillaha · 6157670074 · ldillaha@harrowinc.com
Always discuss trial participation with your own doctor first.
| Ridge Eye Care, Inc. | Chico, California, United States | Recruiting |
| Icon Eye Care | Grand Junction, Colorado, United States | Recruiting |
| Levenson Eye Associates | Jacksonville, Florida, United States | Recruiting |
| Maryland Vision Institute | Hagerstown, Maryland, United States | Recruiting |
| Vance Thompson Vision- Alexandria | Alexandria, Minnesota, United States | Recruiting |
| Tekwani Vision Center | Bay Saint Louis, Mississippi, United States | Recruiting |
| Bergstrom Eye Research | Fargo, North Dakota, United States | Recruiting |
| Vance Thompson Vision, ND | West Fargo, North Dakota, United States | Recruiting |
| Northeastern Eye Institute | Scranton, Pennsylvania, United States | Recruiting |
| Conway Ophthalmology | Conway, South Carolina, United States | Recruiting |
| Vance Thompson Vision | Sioux Falls, South Dakota, United States | Recruiting |
| Utah Eye Centers- Pleasant Grove | Pleasant Grove, Utah, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06383273