AzTrials
AzTrials

CataractPhase 3NCT06383273

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

A Phase 3 study testing MELT-300 sublingual tablet and Midalozam sublingual tablet in people with Cataract, run by Melt Pharmaceuticals at 12 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Cataract
What is being tested?
MELT-300 sublingual tablet and Midalozam sublingual tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
528 participants
Where
12 sitesUnited States
Study dates
1 May 2024to Jan 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 23Show fewer
  • 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
  • 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
  • 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
  • Illicit drug use or alcohol abuse based on medical history, or currently engaged in illicit drug use or alcohol abuse.
  • 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.
  • 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
  • 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

Trial locations and contacts

12 sites in 1 country.

Giovanni DeCastro contact

6157670074

gdecastro@meltpharma.com

Larry Dillaha contact

6157670074

ldillaha@harrowinc.com

12 sites in 1 country

United States12 sites, 12 recruiting

  • Vance Thompson Vision- Alexandria

    Alexandria, Minnesota, 56308

    Isaac McCoy

    Dr. Deborah Ristvedt

    Recruiting

  • Tekwani Vision Center

    Bay Saint Louis, Mississippi, 63128

    Amber Putman

    Dr. Navin Tekwani

    Recruiting

  • Ridge Eye Care, Inc.

    Chico, California, 95928

    Yasmin Hauenstein

    Dr. Douglas McGraw

    Recruiting

  • Conway Ophthalmology

    Conway, South Carolina, 29526

    Rebecca Thigpen

    Dr. Charles Proctor

    Recruiting

  • Bergstrom Eye Research

    Fargo, North Dakota, 58103

    Angela Callaghan

    Dr. Lance Bergstrom

    Recruiting

  • Icon Eye Care

    Grand Junction, Colorado, 81501

    Cordy Brophy

    Dr. James Fox

    Recruiting

  • Maryland Vision Institute

    Hagerstown, Maryland, 21740

    Irina Price

    Dr. Augustus "Gus" Stern

    Recruiting

  • Levenson Eye Associates

    Jacksonville, Florida, 32204

    Vontrece Williams

    Dr. Jeffrey Levenson

    Recruiting

  • Utah Eye Centers- Pleasant Grove

    Pleasant Grove, Utah, 84062

    Rachel Buchanan

    Dr. David Griffin

    Recruiting

  • Northeastern Eye Institute

    Scranton, Pennsylvania, 18503

    Patti Myers

    Dr. William Jordan Jr.

    Recruiting

  • Vance Thompson Vision

    Sioux Falls, South Dakota, 57108

    Jason Meyer

    Dr. Daniel Terveen

    Recruiting

  • Vance Thompson Vision, ND

    West Fargo, North Dakota, 58078

    Sarah Thiede

    Dr. Michael Greenwood

    Recruiting

Other trials in United States

About this study

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)

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:

Read more
  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.

Read the detailed 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

  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
Cataract
Being tested
MELT-300 sublingual tablet, Midalozam sublingual tablet, Placebo sublingual tablet
Keywords
Cataract surgery, Intraocular pressure, Intraoperative ocular pain, Sedation, Lens replacement, MELT-300, Cataract extraction
Medical subject headings
Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MELT-300 sublingual tabletDrug

    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 tabletDrug

    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 tabletDrug

    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.

Study groups in NCT06383273
Study groupRoleWhat they receive
MELT-300 sublingual tabletExperimentalParticipants will receive a single dose of MELT-300 sublingual, tablet containing 3 mg of midazolam and 50 mg of ketamine.
Receives: Drug: MELT-300 sublingual tablet
Midalozam sublingual tabletActive comparatorParticipants will receive a single dose of midazolam 3 mg sublingual tablet.
Receives: Drug: Midalozam sublingual tablet
Placebo sublingual tabletPlacebo comparatorParticipants will receive a single dose of a matching placebo sublingual tablet.
Receives: Drug: Placebo sublingual tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (15)

  1. Percentage of Participants Requiring Rescue Sedation Medication

    Rescue sedation medication (i.e., intravenous midazolam) at a dose determined by Investigator or anesthesiologist may be given. Use of rescue sedation medication during surgery will be allowed if a participant's RSS score is < 2.

    Measured: Preoperative (Day 1) and Intraoperative (Day 1)

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

    Participants achieving target sedation level RSS level 2 or 3 by the start of surgery without need for rescue sedation medication.

    Measured: Preoperative (Day 1)

  3. Percentage of Participants Requiring Rescue Sedation Medication Preoperatively

    Rescue sedation medication (i.e., intravenous midazolam) at a dose determined by Investigator or anesthesiologist may be given. Use of rescue sedation medication during surgery will be allowed if a participant's RSS score is < 2.

    Measured: Preoperative (Day 1)

  4. Percentage of Participants Requiring Rescue Sedation Medication Intraoperatively

    Rescue sedation medication (i.e., intravenous midazolam) at a dose determined by Investigator or anesthesiologist may be given. Use of rescue sedation medication during surgery will be allowed if a participant's RSS score is < 2.

    Measured: Intraoperative (Day 1)

  5. Assessment of Sedation Scores in Participants Without Requiring Rescue Sedation Medication

    Target sedation level (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).

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

  6. Percentage of Participants Able to Complete the Surgery

    Participants achieving the target sedation level (RSS level 2 or 3) by the start of surgery without need for rescue sedation medication, no requirement for intraoperative sedation medication.

    Measured: Postoperative (Day 1)

  7. Percentage of Participants Able to Complete the Surgery Without Intervention (Other Than Rescue Sedation Medication)

    Measured: Postoperative (Day 1)

  8. Duration to Achieve Preoperative Target Sedation (RSS level 2 or 3)

    Measurement of duration (time taken) to achieve target sedation level (RSS level 2 or 3) by the start of surgery.

    Measured: Preoperative (Day 1)

  9. Percentage of Participants Reporting Treatment Emergent Adverse Events (TEAEs)

    An adverse event is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

    Measured: Baseline, Preoperative (Day 1), Intraoperative (Day 1), Postoperative (Day 1), and Day 3 ± 1 post dose of study medication

  10. Percentage of Participants Reporting Adverse Events Special Interest (AESIs)

    The prespecified AESI include:

    1. AEs representing ketamine emergence delirium (i.e.., hallucinations, unpleasant/bad dreams, vivid imagery, confusional state, excitement, behavior abnormal, agitation),
    2. Respiratory AEs (i.e.., respiratory depression, hypoventilation, dyspnea, oxygen desaturation, respiratory arrest, airway obstruction),
    3. Cardiovascular AEs (i.e.., hypotension, blood pressure increased, hypertension [new onset or worsened], bradycardia/tachycardia, cardiac arrest, cardiac decompensation),
    4. Neurocognitive AEs (i.e.., confusional state, amnesia, memory impairment, attention impaired, disorientation, delirium).
    5. Abuse-related AEs
    6. Oversedation (i.e.. sedation excessive) requiring the use of flumazenil
    7. Oral/pharyngeal AEs (i.e.. changes to tongue, oral cavity [active infection, mucositis, cold sores, canker sores, vesicles, viral lesions, stomatitis, periodontal disease], and/or oral/pharyngeal function [hypoesthesia, taste disorders, dysphagia])

    Measured: Baseline, Preoperative (Day 1), Intraoperative (Day 1), Postoperative (Day 1), and Day 3 ± 1 post dose of study medication

  11. Mean Change from Baseline in Blood Pressure (mmHg)

    Measured: Baseline, Preoperative (Day 1), Intraoperative (Day 1), Postoperative (Day 1), and Day 3 ± 1 post dose of study medication

  12. Mean Change from Baseline in Heart Rate [beats per minute (bpm)]

    Measured: Baseline, Preoperative (Day 1), Intraoperative (Day 1), Postoperative (Day 1), and Day 3 ± 1 post dose of study medication

  13. Mean Change from Baseline in Respiratory Rate (breath per minute)

    Measured: Baseline, Preoperative (Day 1), Intraoperative (Day 1), Postoperative (Day 1), and Day 3 ± 1 post dose of study medication

  14. Mean Change from Baseline in Body Temperature (degrees Fahrenheit)

    Measured: Baseline, Preoperative (Day 1), Intraoperative (Day 1), Postoperative (Day 1), and Day 3 ± 1 post dose of study medication

  15. Mean Change from Baseline in Pulse Oximetry (%)

    Measured: Baseline, Preoperative (Day 1), Intraoperative (Day 1), Postoperative (Day 1), and Day 3 ± 1 post dose of study medication

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2024
  2. Study start1 May 2024
  3. Primary completionDec 2024 (estimated)
  4. Study completionJan 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, Double-Masked, Placebo-Controlled, Parallel-Group, Multi-Center Study
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
528 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06383273
Sponsor's protocol ID
MELT-3-001
Status last verified
Aug 2024
First submitted
17 Apr 2024
Last updated
2 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MELT-300 sublingual tablet and Midalozam sublingual tablet in people with Cataract, run by Melt Pharmaceuticals at 12 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Giovanni DeCastro (6157670074, gdecastro@meltpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving Successful Procedural Sedation (time frame: Preoperative (Day 1), Intraoperative (Day 1), and Postoperative (Day 1)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06383273.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in