MELT-300 for Sedation in Cataract Surgery

Recruiting at 12 trial locations

Overseen By Larry Dillaha

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Melt Pharmaceuticals

Must not be taking: Benzodiazepines, Antidepressants, Sleep medications

Disqualifiers: Bilateral cataract surgery, Benzodiazepine sensitivity, Ocular inflammation, Oral infections, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

528 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests MELT-300, a new medication for sedation during cataract surgeries. It aims to determine if MELT-300 is more effective than a placebo and the standard drug midazolam in helping patients relax before their procedure. The study will also assess the onset speed of sedation and monitor any side effects. Participants undergoing cataract surgery on one eye, with no known allergies to the medication's components, might be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial requires that any medications affecting the central nervous system, like benzodiazepines or antidepressants, must be stable for at least 30 days before starting the trial. If you're on a sleep medication, you shouldn't change your dose or start a new one within 3 days of the trial. Please discuss your specific medications with the trial team to ensure they meet these criteria.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study, MELT-300, found that a combination of midazolam and ketamine was more effective for sedation during cataract surgery than midazolam alone or a placebo. The treatment was generally well-tolerated, with no serious safety concerns. Some participants experienced mild side effects, such as dizziness or drowsiness, but these were not severe.

MELT-300 is now undergoing testing in a late-stage clinical trial, indicating existing evidence of its safety for humans. Midazolam is a well-known sedative used in many medical procedures, with well-documented safety. Although ketamine is newer for this use, it has been studied and used in controlled settings. Its inclusion in MELT-300 is being closely monitored to ensure safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about MELT-300 for sedation in cataract surgery because it offers a unique combination of midazolam and ketamine in a single sublingual tablet. Unlike traditional options, which often require intravenous administration, this tablet dissolves under the tongue, potentially providing a simpler and more comfortable experience for patients. The combination of midazolam and ketamine might offer enhanced sedation with rapid onset while minimizing the need for multiple drugs or delivery methods during surgery.

What evidence suggests that MELT-300 might be an effective treatment for sedation in cataract surgery?

Research has shown that MELT-300, which participants in this trial may receive, effectively helps patients relax during cataract surgery. Studies found it works better than both a placebo and a common sedative called sublingual midazolam, which are also being tested in this trial. Specifically, MELT-300 was more successful at keeping patients calm during the procedure. MELT-300 combines two drugs, midazolam and ketamine, both known for their calming effects. The ketamine in MELT-300 appears to enhance the calming effect more than midazolam alone. Overall, MELT-300 provides strong support for keeping patients relaxed during cataract surgery. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

Adults over 18 needing cataract surgery can join this trial. They must understand and follow the study's rules, avoid alcohol before surgery, and women must not be pregnant or use reliable birth control. People with certain health issues or taking specific drugs may not qualify.

Inclusion Criteria

I can avoid drinking alcohol 24 hours before the study starts.

I am scheduled for cataract surgery with lens replacement under local anesthesia.

I agree to participate in the study and have signed all required consent forms.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Preoperative

Participants are admitted to the study unit and randomized to receive study medication 30 minutes before planned surgery

1 day

1 visit (in-person)

Intraoperative

Efficacy and safety assessments are performed during the surgery

1 day

1 visit (in-person)

Postoperative

Safety assessments are performed immediately after surgery and on Day 3 post dose

3 days

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• MELT-300

Trial Overview The trial tests MELT-300's effectiveness for sedation during cataract surgery compared to a placebo and midazolam alone. It checks how quickly it works and its safety by monitoring participants before, during, after surgery on Day 1, and again on Day 3.

How Is the Trial Designed?

Group I: MELT-300 sublingual tablet Experimental Treatment 1 Intervention

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

Group II: Midalozam sublingual tablet Active Control 1 Intervention

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

Group III: Placebo sublingual tablet Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Melt Pharmaceuticals

Lead Sponsor

Trials

4

Recruited

910+

Pharmalex

Collaborator

Trials

2

Recruited

620+

Evolution Research Group

Collaborator

Trials

2

Recruited

560+

MedTrials Incorporated

Collaborator

Trials

1

Recruited

530+

Catalent

Industry Sponsor

Trials

4

Recruited

650+

Citations

1. meltpharma.com meltpharma.com/news-releases/news-release-details/melt-pharmaceuticals-reports-positive-phase-3-topline-efficacy

Melt Pharmaceuticals Reports Positive Phase 3 Topline ... MELT-300 demonstrates statistically superior compared to both sublingual midazolam (P=0.009) and placebo (P<0.001) for providing successful procedural sedation.

2. clinicaltrialsarena.com clinicaltrialsarena.com/news/melt-melt-300-cataract/

Melt reports outcomes from trial of MELT-300 for cataract ... The results showed that MELT-300 was statistically superior in providing procedural sedation across all comparator groups.

3. empr.com empr.com/news/sublingual-midazolam-ketamine-effective-for-procedural-sedation-during-cataract-surgery/

Sublingual Midazolam/Ketamine Effective for Procedural ... Findings showed MELT-300 was statistically superior to both sublingual midazolam and placebo for providing successful procedural sedation. ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06383273

A Study to Evaluate Efficacy and Safety of MELT-300 for ... The goal of this clinical trial is to learn if MELT-300 works on procedural sedation in adult participants undergoing cataract extraction with lens ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12269492/

A double-blind crossover non-inferiority clinical trial (BEKEF ... Conclusions. Ketamine combined with midazolam is a safe and effective alternative to fentanyl-based sedation for cataract surgery, providing ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05133518

NCT05133518 | A Study of MELT-300 (Midazolam and ... The study aims to evaluate the efficacy and safety of MELT-300 and the contribution of midazolam and ketamine components for procedural sedation prior to ...

7. meltpharma.com meltpharma.com/news-releases/news-release-details/melt-pharmaceuticals-melt-300-midazolam-3mg-and-ketamine-50mg

Melt Pharmaceuticals' MELT-300 (Midazolam 3mg and ... MELT-300 combines fixed doses of midazolam (3mg) and ketamine (50mg) in one rapidly dissolving tablet (RDT) that is administered sublingually for procedural ...