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Procedural Sedation
MELT-300 for Sedation in Cataract Surgery
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
Pivotal Trial
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.
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.
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 belowSelect...
I am scheduled for cataract surgery with lens replacement under local anesthesia.
Select...
I understand the information given to me and can make decisions about my health care.
Select...
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of Participants Achieving Successful Procedural Sedation
Secondary study objectives
Assessment of Sedation Scores in Participants Without Requiring Rescue Sedation Medication
Duration to Achieve Preoperative Target Sedation (RSS level 2 or 3)
Percentage of Participants Able to Complete the Surgery
+6 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
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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
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