Actively Recruiting
A Phase 3, Randomized, Double-Masked, Placebo-Controlled Study to Evaluate Efficacy and Safety of MELT-300 for Sedation in Adults Undergoing Cataract Extraction With Lens Replacement
Led by Melt Pharmaceuticals · Updated on 2024-08-02
528
Participants Needed
12
Research Sites
4 weeks
Total Duration
On this page
Sponsors
M
Melt Pharmaceuticals
Lead Sponsor
M
MedTrials Incorporated
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of MELT-300 on procedural sedation in adults undergoing cataract extraction with lens replacement (CELR). This Phase 3 clinical trial aims to compare MELT-300 with a placebo and an active comparator, sublingual midazolam, to assess the contribution of ketamine in the combined drug product. The study focuses on the effectiveness and safety of MELT-300 during and after cataract surgery. Participants will be randomly assigned to one of three groups: MELT-300 (a sublingual tablet containing 3 mg midazolam and 50 mg ketamine), midazolam alone (3 mg sublingual tablet), or a placebo tablet. They will receive a single dose of the assigned medication approximately 30 minutes before surgery without food or water. The surgery will be performed under topical anesthesia, and the study medication effects will be assessed before, during, and after the procedure. Participants will be admitted on the day of surgery and monitored throughout. Researchers will assess sedation levels, the need for additional sedation or pain medication, and the ability to complete surgery. Safety will be tracked through adverse event monitoring, vital signs, and physical exams at baseline, during surgery, and up to three days after medication. The primary outcome measured is the percentage of participants achieving successful procedural sedation at various time points on the day of surgery.
CONDITIONS
Brief 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...
- Participants must be 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 contraception from Day 1 to 2 days after study drug
- Will refrain from alcohol within 24 hours before randomization
- Able to provide informed consent and comply with study procedures
You will not qualify if you...
- Scheduled for simultaneous bilateral or second-eye cataract surgery on the same day
- Known allergies to benzodiazepines, ketamine, or certain local anesthetics
- Intraocular pressure above 30 mmHg in either eye at screening
- History of iris inflammation or trauma in the study eye
- Active corneal or intraocular inflammation or infection in either eye
- Recent intraocular surgery or planned additional ocular surgery during cataract procedure
- Active oral infections, inflammation, or history of oral piercings or significant dental disease
- Nursing women or planning to nurse during the study
- Significant medical conditions that could affect safety or study results
- Use of unstable doses of antihypertensive, diabetic, CNS active drugs, or recent sleep medication changes
- Current or recent illicit drug use or alcohol abuse
- Reduced kidney function with creatinine clearance below 60 mL/min
- Abnormal liver function tests beyond specified limits
- Other lab abnormalities or conditions considered risky by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive a single dose of study medication (MELT-300, midazolam, or placebo) 30 minutes before cataract extraction surgery. Procedural sedation and safety are monitored before, during, and immediately after surgery.
1 baseline visit and surgery day assessments
Duration - 3 ± 1 days post-treatment
Participants are monitored for safety, including adverse events and vital signs, on Day 3 after receiving the study medication.
1 follow-up visit
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
L
Larry Dillaha
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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