Actively Recruiting
A Study to Evaluate Efficacy and Safety of MELT-300 for Procedural Sedation in Subjects Undergoing Cataract Extraction With Lens Replacement (CELR)
Led by Melt Pharmaceuticals · Updated on 2024-08-02
528
Participants Needed
12
Research Sites
35 weeks
Total Duration
On this page
Sponsors
M
Melt Pharmaceuticals
Lead Sponsor
M
MedTrials Incorporated
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Evaluate Efficacy and Safety of MELT-300 for Procedural Sedation in Subjects Undergoing Cataract Extraction With Lens Replacement (CELR)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Scheduled for unilateral primary cataract extraction with lens replacement under topical anesthesia
- Women of childbearing potential must have a negative pregnancy test and use double barrier birth control or abstain from sexual activity from Day 1 until 2 days after study drug administration
- Willing to avoid alcohol consumption within 24 hours of randomization
- Able and willing to provide informed consent
- Agree to comply fully with study procedures and restrictions
You will not qualify if you...
- Scheduled for simultaneous bilateral or second-eye cataract surgery on the same day
- Known sensitivity to benzodiazepines, ketamine, proparacaine, ester-type local anesthetics, or benzalkonium chloride
- Intraocular pressure greater than 30 mmHg in either eye at screening
- History of iritis or ocular trauma with iris damage in the study eye
- Active corneal disease other than dry eye, eye inflammation, or active eye infection
- Eye surgery other than cataract surgery within 3 months (non-laser) or 30 days (laser) prior to surgery
- Planned additional ocular surgery during cataract surgery
- Active infection or inflammation of the oral cavity, history of oral piercings, significant dental disease, or swallowing difficulties
- Nursing women or planning to nurse during the study
- Significant medical conditions that may interfere with the study or increase risk, as judged by the investigator
- Use of unstable doses of antihypertensive, diabetic, CNS active drugs, or sleep medications
- Current or recent illicit drug use or alcohol abuse
- Creatinine clearance less than 60 mL/min
- Elevated liver enzymes above specified limits unless due to Gilbert syndrome
- Any other abnormal labs or conditions deemed risky or confounding by the investigator
AI-Screening
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Trial Site Locations
Total: 12 locations
1
Ridge Eye Care, Inc.
Chico, California, United States, 95928
Actively Recruiting
2
Icon Eye Care
Grand Junction, Colorado, United States, 81501
Actively Recruiting
3
Levenson Eye Associates
Jacksonville, Florida, United States, 32204
Actively Recruiting
4
Maryland Vision Institute
Hagerstown, Maryland, United States, 21740
Actively Recruiting
5
Vance Thompson Vision- Alexandria
Alexandria, Minnesota, United States, 56308
Actively Recruiting
6
Tekwani Vision Center
Bay Saint Louis, Mississippi, United States, 63128
Actively Recruiting
7
Bergstrom Eye Research
Fargo, North Dakota, United States, 58103
Actively Recruiting
8
Vance Thompson Vision, ND
West Fargo, North Dakota, United States, 58078
Actively Recruiting
9
Northeastern Eye Institute
Scranton, Pennsylvania, United States, 18503
Actively Recruiting
10
Conway Ophthalmology
Conway, South Carolina, United States, 29526
Actively Recruiting
11
Vance Thompson Vision
Sioux Falls, South Dakota, United States, 57108
Actively Recruiting
12
Utah Eye Centers- Pleasant Grove
Pleasant Grove, Utah, United States, 84062
Actively Recruiting
Research Team
G
Giovanni DeCastro
CONTACT
L
Larry Dillaha
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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