Vance Thompson Vision | Sioux Falls, SD
Status and phase
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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:
Eligible participants will admitted to the study unit on Day 1. Participants will be randomized prior to surgery 4:1:1 to
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.
Full description
This is a Phase 3, randomized, double-masked, placebo-controlled, parallel-cohort, multicenter study to evaluate the efficacy and safety of MELT-300 compared with placebo on procedural sedation in adult participants undergoing CELR. An active comparator, SL midazolam, is also included in the trial, in part, to confirm the benefit of inclusion of ketamine in the combined drug product.
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
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.
Enrollment
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Inclusion criteria
Participants must meet all of the following in order to be enrolled into the study:
Exclusion criteria
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
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
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
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.
Women who are nursing a child or plan to nurse a child during the study
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
Use of disallowed medications including the following:
Illicit drug use or alcohol abuse based on medical history, or currently engaged in illicit drug use or alcohol abuse.
Creatinine clearance rate < 60 mL/min estimated using the CKD-EPI 2021cr (NKD) equation
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
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
Primary purpose
Allocation
Interventional model
Masking
528 participants in 3 patient groups, including a placebo group
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Central trial contact
Larry Dillaha; Giovanni DeCastro
Data sourced from clinicaltrials.gov
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