A Study to Evaluate Efficacy and Safety of MELT-300 for Procedural Sedation in Subjects Undergoin… (NCT06383273) | Clinical Trial Compass
RecruitingPhase 3
A Study to Evaluate Efficacy and Safety of MELT-300 for Procedural Sedation in Subjects Undergoing Cataract Extraction With Lens Replacement (CELR)
United States528 participantsStarted 2024-05-01
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Males and females ≥ 18 years of age
✓. Are to undergo unilateral primary CELR under topical anesthesia, with a phacoemulsification device and insertion of an intraocular lens (no restrictions on lens type)
✓. For women of childbearing potential (WOCBP), have a negative urine pregnancy test, and abstain from sexual activity or use a double barrier method (e.g. condom and diaphragm) of birth control from Day 1 and up to 2 days after study drug administration.
✓. Willing to refrain from alcohol consumption within 24 hours of randomization
✓. Are competent to provide informed consent
✓. Voluntarily provide informed consent in accordance with governing International Review Board (IRB) requirements and provide Health Insurance Portability and Accountability Act (HIPAA) authorization, prior to any procedures or evaluations performed specifically for the sole purpose of the study
✓. Indicate they understand and are able, willing, and likely to fully comply with study procedures and restrictions
Exclusion criteria
What they're measuring
1
Percentage of Participants Achieving Successful Procedural Sedation
. Subjects scheduled for simultaneous bilateral or 2nd-eye cataract surgery (subjects scheduled for a future 2nd eye cataract surgery are eligible for the study)
✕. Known sensitivity to benzodiazepines or ketamine
✕. Known sensitivity to -caines (including proparacaine, ester-type local anesthetics), benzalkonium chloride (BAK)
✕. Intraocular pressure (IOP) \> 30 mmHg in the study eye or fellow eye at screening.
✕. History of iritis, or any ocular trauma with iris damage in the study eye
✕. Presence of active corneal pathology other than dry eye per slit lamp and external eye exam at screening in either eye
✕. Presence of extraocular/intraocular inflammation in either eye
✕. Presence of active bacterial and/or viral infection in either eye