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RecruitingNCT06383273Updated Aug 2, 2024

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 interventional study of MELT-300 sublingual tablet and Midalozam sublingual tablet in Cataract, sponsored by Melt Pharmaceuticals. Recruiting at 12 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-08-02.

Sponsored by Melt Pharmaceuticals · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Started May 2024; still recruiting 2 years 5 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
528
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Cataract

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Keywords

  • Cataract surgery
  • Intraocular pressure
  • Intraoperative ocular pain
  • Sedation
  • Lens replacement
  • MELT-300
  • Cataract extraction
03

In context

Cataract

1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's planned enrollment of 528 is above the median of 80 across 1,155 interventional studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Melt Pharmaceuticals is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

  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

Exclusion Criteria:

  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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
528 participants (estimated)

Study arms

  • Experimental
    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.

    Drug: MELT-300 sublingual tablet

  • Active comparator
    Midalozam sublingual tablet

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

    Drug: Midalozam sublingual tablet

  • Placebo comparator
    Placebo sublingual tablet

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

    Drug: Placebo sublingual tablet

Interventions

  • DrugMELT-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.

  • DrugMidalozam 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.

  • DrugPlacebo 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.

06

What researchers measure

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.

    Time frame: Preoperative (Day 1), Intraoperative (Day 1), and Postoperative (Day 1)

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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).

    Time frame: 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.

    Time frame: Postoperative (Day 1)

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

    Time frame: 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.

    Time frame: 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.

    Time frame: 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 \[hypoesthesia, taste disorders, dysphagia\])

    Time frame: 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)

    Time frame: 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)]

    Time frame: 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)

    Time frame: 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)

    Time frame: 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 (%)

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

07

Study locations

12 of 12 sites recruiting
  • Ridge Eye Care, Inc.
    Chico, California 95928, United States
    • Yasmin Hauenstein · Contact
    • Dr. Douglas McGraw · Principal investigator
    Recruiting
  • Icon Eye Care
    Grand Junction, Colorado 81501, United States
    • Cordy Brophy · Contact
    • Dr. James Fox · Principal investigator
    Recruiting
  • Levenson Eye Associates
    Jacksonville, Florida 32204, United States
    • Vontrece Williams · Contact
    • Dr. Jeffrey Levenson · Principal investigator
    Recruiting
  • Maryland Vision Institute
    Hagerstown, Maryland 21740, United States
    • Irina Price · Contact
    • Dr. Augustus "Gus" Stern · Principal investigator
    Recruiting
  • Vance Thompson Vision- Alexandria
    Alexandria, Minnesota 56308, United States
    • Isaac McCoy · Contact
    • Dr. Deborah Ristvedt · Principal investigator
    Recruiting
  • Tekwani Vision Center
    Bay Saint Louis, Mississippi 63128, United States
    • Amber Putman · Contact
    • Dr. Navin Tekwani · Principal investigator
    Recruiting
  • Bergstrom Eye Research
    Fargo, North Dakota 58103, United States
    • Angela Callaghan · Contact
    • Dr. Lance Bergstrom · Principal investigator
    Recruiting
  • Vance Thompson Vision, ND
    W. Fargo, North Dakota 58078, United States
    • Sarah Thiede · Contact
    • Dr. Michael Greenwood · Principal investigator
    Recruiting
  • Northeastern Eye Institute
    Scranton, Pennsylvania 18503, United States
    • Patti Myers · Contact
    • Dr. William Jordan Jr. · Principal investigator
    Recruiting
  • Conway Ophthalmology
    Conway, South Carolina 29526, United States
    • Rebecca Thigpen · Contact
    • Dr. Charles Proctor · Principal investigator
    Recruiting
  • Vance Thompson Vision
    Sioux Falls, South Dakota 57108, United States
    • Jason Meyer · Contact
    • Dr. Daniel Terveen · Principal investigator
    Recruiting
  • Utah Eye Centers- Pleasant Grove
    Pleasant Grove, Utah 84062, United States
    • Rachel Buchanan · Contact
    • Dr. David Griffin · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06383273
Lead sponsor
Melt Pharmaceuticals
Collaborators
MedTrials Incorporated, Evolution Research Group, Catalent, Pharmalex
Responsible party
Sponsor
First posted
Apr 25, 2024
Start date
May 1, 2024
Primary completion
Dec 2024 (estimated)
Completion
Jan 2025 (estimated)
Last update
Aug 2, 2024

Study contacts

Giovanni DeCastro
Contact
gdecastro@meltpharma.com
6157670074
Larry Dillaha
Contact
ldillaha@harrowinc.com
6157670074

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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