A Study to Evaluate Efficacy and Safety of MELT-300 for Procedural Sedation in Subjects Undergoing Cataract Extraction With Lens Replacement (CELR)
NCT ID: NCT06383273
Last Updated: 2024-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
528 participants
INTERVENTIONAL
2024-05-01
2025-01-31
Brief Summary
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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.
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Detailed Description
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Approximately 528 participants will be enrolled in 3 parallel treatment arms to assess efficacy endpoints.
Eligible participants will be 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 \[i.e.. 3 drops of chloroprocaine hydrochloride ophthalmic gel)\].
Efficacy assessments will be performed after study medication administration before surgery, intraoperatively, and postoperative on Day 1 (end of surgery defined as just prior to drape removal). Efficacy assessments will include assessments of sedation, need for rescue medication for sedation, need for rescue medication for pain, and the ability to complete the surgery.
Safety will be monitored at baseline, intraoperatively, postoperatively on Day 1, and on Day 3 ± 1 day post dose of study medication. Safety assessment will include monitoring of AEs, vital sign measurements, and physical examinations.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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MELT-300 sublingual tablet
Participants will receive a single dose of MELT-300 sublingual, tablet containing 3 mg of midazolam and 50 mg of ketamine.
MELT-300 sublingual tablet
Each dose of MELT-300 will be provided as a single sublingual tablet, containing 3 mg midazolam and 50 mg ketamine. Participants will receive 1 sublingual tablet of study medication 30 (± 5) minutes prior to planned surgery start, without food or water.
Midalozam sublingual tablet
Participants will receive a single dose of midazolam 3 mg sublingual tablet.
Midalozam sublingual tablet
Each dose of midazolam will be provided as a single sublingual tablet, containing 3 mg midazolam. Participants will receive 1 sublingual tablet of study medication 30 (± 5) minutes prior to planned surgery start, without food or water.
Placebo sublingual tablet
Participants will receive a single dose of a matching placebo sublingual tablet.
Placebo sublingual tablet
Each dose of placebo will be provided as a matching sublingual tablet, containing placebo. Participants will receive 1 sublingual tablet of study medication 30 (± 5) minutes prior to planned surgery start, without food or water.
Interventions
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MELT-300 sublingual tablet
Each dose of MELT-300 will be provided as a single sublingual tablet, containing 3 mg midazolam and 50 mg ketamine. Participants will receive 1 sublingual tablet of study medication 30 (± 5) minutes prior to planned surgery start, without food or water.
Midalozam sublingual tablet
Each dose of midazolam will be provided as a single sublingual tablet, containing 3 mg midazolam. Participants will receive 1 sublingual tablet of study medication 30 (± 5) minutes prior to planned surgery start, without food or water.
Placebo sublingual tablet
Each dose of placebo will be provided as a matching sublingual tablet, containing placebo. Participants will receive 1 sublingual tablet of study medication 30 (± 5) minutes prior to planned surgery start, without food or water.
Eligibility Criteria
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Inclusion Criteria
1. Males and females ≥ 18 years of age
2. Are to undergo unilateral primary CELR under topical anesthesia, with a phacoemulsification device and insertion of an intraocular lens (no restrictions on lens type)
3. 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.
4. Willing to refrain from alcohol consumption within 24 hours of randomization
5. Are competent to provide informed consent
6. 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
7. Indicate they understand and are able, willing, and likely to fully comply with study procedures and restrictions
Exclusion Criteria
2. Known sensitivity to benzodiazepines or ketamine
3. Known sensitivity to -caines (including proparacaine, ester-type local anesthetics), benzalkonium chloride (BAK)
4. Intraocular pressure (IOP) \> 30 mmHg in the study eye or fellow eye at screening.
5. History of iritis, or any ocular trauma with iris damage in the study eye
6. Presence of active corneal pathology other than dry eye per slit lamp and external eye exam at screening in either eye
7. Presence of extraocular/intraocular inflammation in either eye
8. Presence of active bacterial and/or viral infection in either eye
9. History of intraocular non-laser surgery in the study eye within the 3 months prior to day of surgery, or intraocular laser surgery in the study eye within 30 days prior to the day of surgery
10. Requiring or planning other additional ocular surgery during the cataract surgery (e.g. glaucoma surgery (\[minimally invasive or traditional\], limbal relaxing incisions, etc.) or performing laser-assisted CELR
11. Presence of active infection, mucositis, cold sores, canker sores, vesicles, viral lesions, local irritation/inflammation, or periodontal disease of the oral cavity. In addition, evidence of piercings of the tongue or anywhere in the oral cavity, history of oral cavity piercings, history of significant dental disease, or history of dysphagia.
12. Women who are nursing a child or plan to nurse a child during the study
13. Have a history or clinical manifestations (e.g., signs, symptoms, laboratory values, diagnostic imaging, etc.) of significant gastrointestinal, cardiovascular, hepatic, renal, hematological, endocrine, neurological, psychiatric, respiratory, or other medical condition that in the opinion of the investigator might confound the study results or pose additional risk in administering the study procedures
14. Use of disallowed medications including the following:
1. Antihypertensive agent or diabetic regimen at a dose that has not been stable for at least 30 days prior to Day 1, or which is not expected to remain stable throughout the study
2. Central nervous system (CNS) active drugs such as benzodiazepines, tricyclic antidepressants, serotonin and norepinephrine reuptake inhibitors (SNRIs), or selective serotonin reuptake inhibitors (SSRIs) that have not been stable for at least 30 days prior to Day 1, or which is not expected to remain stable throughout the study
3. Initiating the use of, switching to a different, or increasing the dose of a sleep medication (e.g. lorazepam, zolpidem, etc) within 3 days of randomization
15. Illicit drug use or alcohol abuse based on medical history, or currently engaged in illicit drug use or alcohol abuse.
1. Alcohol abuse is defined as 5 or more drinks in one sitting or 15 or more drinks in a week for men and 4 or more drinks in one sitting or 8 or more drinks in a week for women. A drink is considered a 1.5 oz shot, 12 oz of beer, or 5 oz of wine.
2. However, patients with a medical history of illicit drug use or alcohol abuse ≥ 5 years prior to the time of screening and who have recovered and have been drug/alcohol free for at least that period of time (i.e., 5 years) can be enrolled C. Patients with a medical history of medical or recreational marijuana (including THC and /or CBD) use ≥ 1 year prior to the time of screening and have been marijuana free for at least that period of time (i.e. 1 year) can be enrolled
16. Creatinine clearance rate \< 60 mL/min estimated using the CKD-EPI 2021cr (NKD) equation
17. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase (ALP) \> 2.5 times upper limit of normal (ULN), or total bilirubin \> 1.5 x ULN. In cases of documented Gilbert syndrome, subjects with elevated bilirubin levels will be permitted to enroll in the study if other liver function tests are within the specified limits
18. Any other abnormal laboratory results or presence of any condition that the Investigator believes would put the subject at risk or confound the interpretation of results
18 Years
65 Years
ALL
No
Sponsors
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MedTrials Incorporated
UNKNOWN
Evolution Research Group
NETWORK
Catalent
INDUSTRY
Pharmalex
UNKNOWN
Melt Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Ridge Eye Care, Inc.
Chico, California, United States
Icon Eye Care
Grand Junction, Colorado, United States
Levenson Eye Associates
Jacksonville, Florida, United States
Maryland Vision Institute
Hagerstown, Maryland, United States
Vance Thompson Vision- Alexandria
Alexandria, Minnesota, United States
Tekwani Vision Center
Bay Saint Louis, Mississippi, United States
Bergstrom Eye Research
Fargo, North Dakota, United States
Vance Thompson Vision, ND
West Fargo, North Dakota, United States
Northeastern Eye Institute
Scranton, Pennsylvania, United States
Conway Ophthalmology
Conway, South Carolina, United States
Vance Thompson Vision
Sioux Falls, South Dakota, United States
Utah Eye Centers- Pleasant Grove
Pleasant Grove, Utah, United States
Countries
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Central Contacts
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Facility Contacts
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Yasmin Hauenstein
Role: primary
Cordy Brophy
Role: primary
Vontrece Williams
Role: primary
Irina Price
Role: primary
Isaac McCoy
Role: primary
Amber Putman
Role: primary
Angela Callaghan
Role: primary
Sarah Thiede
Role: primary
Patti Myers
Role: primary
Rebecca Thigpen
Role: primary
Jason Meyer
Role: primary
Rachel Buchanan
Role: primary
Other Identifiers
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MELT-3-001
Identifier Type: -
Identifier Source: org_study_id
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