RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 3, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group, Multi-Center Study to Evaluate Efficacy and Safety of MELT-300 for Procedural Sedation in Subjects Undergoing Cataract Extraction With Lens Replacement (CELR)

Quick Facts

Study Start:2024-05-01

Study Completion:2025-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06383273

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	1. Subjects scheduled for simultaneous bilateral or 2nd-eye cataract surgery (subjects scheduled for a future 2nd eye cataract surgery are eligible for the study) 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

Inclusion Criteria

Exclusion 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

1. Subjects scheduled for simultaneous bilateral or 2nd-eye cataract surgery (subjects scheduled for a future 2nd eye cataract surgery are eligible for the study)
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

Contacts and Locations

Study Contact

Giovanni DeCastro

CONTACT

6157670074

gdecastro@meltpharma.com

Larry Dillaha

CONTACT

6157670074

ldillaha@harrowinc.com

Study Locations (Sites)

Ridge Eye Care, Inc.

Chico, California, 95928

United States

Icon Eye Care

Grand Junction, Colorado, 81501

United States

Levenson Eye Associates

Jacksonville, Florida, 32204

United States

Maryland Vision Institute

Hagerstown, Maryland, 21740

United States

Vance Thompson Vision- Alexandria

Alexandria, Minnesota, 56308

United States

Tekwani Vision Center

Bay Saint Louis, Mississippi, 63128

United States

Bergstrom Eye Research

Fargo, North Dakota, 58103

United States

Vance Thompson Vision, ND

W. Fargo, North Dakota, 58078

United States

Northeastern Eye Institute

Scranton, Pennsylvania, 18503

United States

Conway Ophthalmology

Conway, South Carolina, 29526

United States

Vance Thompson Vision

Sioux Falls, South Dakota, 57108

United States

Utah Eye Centers- Pleasant Grove

Pleasant Grove, Utah, 84062

United States

Collaborators and Investigators

Sponsor: Melt Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-01

Study Completion Date2025-01

Study Record Updates

Study Start Date2024-05-01

Study Completion Date2025-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Cataract