A Study to Evaluate Efficacy and Safety of MELT-300 for Procedural Sedation in Subjects Undergoing Cataract Extraction With Lens Replacement (CELR)

NCT06383273 | Recruiting Phase 3 FDA Drug

• 1 other identifier: MELT-3-001
• Study Type: interventional
• Target: 528
• Locations: 1 country
• Sites: 12

Brief 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. 1.Does MELT-300 is effective in comparison to placebo on procedural sedation for cataract surgery?
2. 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. 3.To determine the time to achieve preoperative target sedation level with MELT-300
4. 4.What medical problems do participants have when taking MELT-300 vs placebo
5. 5.MELT-300 (i.e. 1 MELT-300 sublingual tablet which contains 3 mg midazolam and 50 mg of ketamine)
6. 6.Midazolam (i.e. 1 matching midazolam sublingual tablet which contains 3 mg midazolam)
7. 7.Placebo (i.e. 1 matching placebo sublingual tablet)

Conditions

Cataract

Keywords

Cataract surgery; Intraocular pressure; Intraoperative ocular pain; Sedation; Lens replacement; MELT-300; Cataract extraction

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving Successful Procedural Sedation

  Successful procedural sedation is defined as achieving target sedation level (Ramsay Sedation Scale \[RSS\] level 2 or 3) by the start of surgery without need for rescue sedation medication, no requirement for intraoperative sedation medication, and able to complete the surgery (i.e. procedural sedation responder). The Ramsay Sedation Scale (RSS) was the first scale to be defined for the sedated participants and was designed as a test of arousability. The Ramsay Scale provides three levels of 'awake' states (score 1-3) and three levels of 'asleep' states (score 4-6). A score of 2 (participant is cooperative, orientated, and tranquil) best fits an optimum sedation level based on the criteria of calm, comfortable, communicative, and cooperative participants.

  Preoperative (Day 1), Intraoperative (Day 1), and Postoperative (Day 1)

Secondary Outcomes (15)

• Percentage of Participants Requiring Rescue Sedation Medication

  Preoperative (Day 1) and Intraoperative (Day 1)

• Percentage of Participants Achieving Preoperative Procedural Sedation Without Need For Rescue Sedation Medication

  Preoperative (Day 1)

• Percentage of Participants Requiring Rescue Sedation Medication Preoperatively

  Preoperative (Day 1)

• Percentage of Participants Requiring Rescue Sedation Medication Intraoperatively

  Intraoperative (Day 1)

• Assessment of Sedation Scores in Participants Without Requiring Rescue Sedation Medication

  Preoperative (Day 1), Intraoperative (Day 1), and Postoperative (Day 1)

Study Arms (3)

MELT-300 sublingual tablet

EXPERIMENTAL

Participants will receive a single dose of MELT-300 sublingual, tablet containing 3 mg of midazolam and 50 mg of ketamine.

Drug: MELT-300 sublingual tablet

Midalozam sublingual tablet

ACTIVE COMPARATOR

Participants will receive a single dose of midazolam 3 mg sublingual tablet.

Drug: Midalozam sublingual tablet

Placebo sublingual tablet

PLACEBO COMPARATOR

Participants will receive a single dose of a matching placebo sublingual tablet.

Drug: Placebo sublingual tablet

Interventions

MELT-300 sublingual tablet DRUG

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.

MELT-300 sublingual tablet

Midalozam sublingual tablet DRUG

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.

Midalozam sublingual tablet

Placebo sublingual tablet DRUG

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.

Placebo sublingual tablet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must meet all of the following in order to be enrolled into the study:
• 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

You may not qualify if:

• 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:
• 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

Sponsors & Collaborators

• Melt Pharmaceuticals: lead
• MedTrials Incorporated: collaborator
• Evolution Research Group: collaborator
• Catalent: collaborator
• Pharmalex: collaborator

Study Sites (12)

Ridge Eye Care, Inc.

Chico, California, 95928, United States

RECRUITING

Icon Eye Care

Grand Junction, Colorado, 81501, United States

RECRUITING

Levenson Eye Associates

Jacksonville, Florida, 32204, United States

RECRUITING

Maryland Vision Institute

Hagerstown, Maryland, 21740, United States

RECRUITING

Vance Thompson Vision- Alexandria

Alexandria, Minnesota, 56308, United States

RECRUITING

Tekwani Vision Center

Bay Saint Louis, Mississippi, 63128, United States

RECRUITING

Bergstrom Eye Research

Fargo, North Dakota, 58103, United States

RECRUITING

Vance Thompson Vision, ND

West Fargo, North Dakota, 58078, United States

RECRUITING

Northeastern Eye Institute

Scranton, Pennsylvania, 18503, United States

RECRUITING

Conway Ophthalmology

Conway, South Carolina, 29526, United States

RECRUITING

Vance Thompson Vision

Sioux Falls, South Dakota, 57108, United States

RECRUITING

Utah Eye Centers- Pleasant Grove

Pleasant Grove, Utah, 84062, United States

RECRUITING

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Central Study Contacts

Giovanni DeCastro

CONTACT

6157670074; gdecastro@meltpharma.com

Larry Dillaha

CONTACT

6157670074; ldillaha@harrowinc.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-masked
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Double-Masked, Placebo-Controlled, Parallel-Group, Multi-Center Study

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 25, 2024
• Study Start: May 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: August 2, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)