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Procedural Sedation

MELT-300 sublingual tablet for Cataract

Phase 3

Recruiting

Research Sponsored by Melt Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Are to undergo unilateral primary CELR under topical anesthesia, with a phacoemulsification device and insertion of an intraocular lens

Are competent to provide informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, preoperative (day 1), intraoperative (day 1), postoperative (day 1), and day 3 ± 1 post dose of study medication

Awards & highlights

Study Summary

This trial aims to see if MELT-300 can effectively be used for sedation during cataract surgery in adults. The study will compare MELT-300 to a placebo and a

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Possible side effects of MELT-300 include typical reactions to sedatives like drowsiness, dizziness, nausea, or changes in blood pressure. Since it contains ketamine, there might also be mood changes or unusual sensations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I understand the information given to me and can make decisions about my health care.

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I am not pregnant and will use double birth control during and 2 days after the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, preoperative (day 1), intraoperative (day 1), postoperative (day 1), and day 3 ± 1 post dose of study medication

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, preoperative (day 1), intraoperative (day 1), postoperative (day 1), and day 3 ± 1 post dose of study medication

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, preoperative (day 1), intraoperative (day 1), postoperative (day 1), and day 3 ± 1 post dose of study medication for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Participants Achieving Successful Procedural Sedation

Secondary outcome measures

Assessment of Sedation Scores in Participants Without Requiring Rescue Sedation Medication

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

Mean Change from Baseline in Blood Pressure (mmHg)

+12 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: MELT-300 sublingual tabletExperimental Treatment1 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 tabletActive Control1 Intervention

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

Group III: Placebo sublingual tabletPlacebo Group1 Intervention

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

PharmalexUNKNOWN

1 Previous Clinical Trials

96 Total Patients Enrolled

Melt PharmaceuticalsLead Sponsor

3 Previous Clinical Trials

380 Total Patients Enrolled

1 Trials studying Cataract

338 Patients Enrolled for Cataract

Evolution Research GroupNETWORK

1 Previous Clinical Trials

36 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are multiple medical facilities in the city conducting this research study?

"The current trial is being conducted at 12 different locations, including Fargo, West Fargo, and Scranton among others. Opting for the site closest to you can reduce travel demands while participating in this study."

Answered by AI

Am I eligible to enroll in this research study?

"Individuals eligible for participation in this trial must have a diagnosis of cataracts and fall between the ages of 18 to 65. The study aims to enroll a total of 486 participants."

Answered by AI

Is this clinical trial enrolling participants who are older than 30 years of age?

"This investigation is open to individuals aged over 18 and under the age of 65."

Answered by AI

Has the sublingual tablet MELT-300 obtained approval from the FDA?

"Our team at Power rates the safety of the MELT-300 sublingual tablet as 3 on our scale due to its Phase 3 trial status, indicating existing efficacy data and robust safety profiles."

Answered by AI

What is the current number of participants being enrolled in this clinical research study?

"Affirmative. The details on clinicaltrials.gov affirm that this medical investigation is actively seeking eligible individuals. Initially shared on the 1st of May, 2024, and most recently revised on the same day. This study aims to enroll 486 participants across a dozen locations."

Answered by AI

Are there any available openings for patients to participate in this medical study?

"Indeed, the details on clinicaltrials.gov specify that this investigation is actively seeking eligible individuals to participate. The trial was initially listed on May 1st, 2024, and most recently revised on the same day in May 2024. A total of 486 participants will be enrolled from a selection of twelve sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "A Study to Evaluate Efficacy and Safety of MELT-300 for Procedural Sedation in Subjects Undergoing Cataract Extraction With Lens Replacement (CELR)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06383273.

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