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

Part of paid clinical trials in Chico, California.

Sponsor
Melt Pharmaceuticals
Study ID
NCT06383273
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Cataract

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • MELT-300 sublingual tablet — DRUG
    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 tablet — DRUG
    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 tablet — DRUG
    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 Details

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.

Key Dates

Start date
May 1, 2024
Status verified
Aug 2024
Primary completion
Dec 31, 2024
Completion
Jan 31, 2025

Study Design

Enrollment
528 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.
  • Active Comparator: Midalozam sublingual tablet
    Participants will receive a single dose of midazolam 3 mg sublingual tablet.
  • Placebo Comparator: Placebo sublingual tablet
    Participants will receive a single dose of a matching placebo sublingual tablet.

Primary Outcome Measure

Percentage of Participants Achieving Successful Procedural Sedation [ Time Frame: Preoperative (Day 1), Intraoperative (Day 1), and Postoperative (Day 1) ]

Central Contacts

Locations (12)

FacilityCityStateZIPSite coordinators
Ridge Eye Care, Inc.ChicoCalifornia95928
Yasmin Hauenstein
Dr. Douglas McGraw (PRINCIPAL_INVESTIGATOR)
Icon Eye CareGrand JunctionColorado81501
Cordy Brophy
Dr. James Fox (PRINCIPAL_INVESTIGATOR)
Levenson Eye AssociatesJacksonvilleFlorida32204
Vontrece Williams
Dr. Jeffrey Levenson (PRINCIPAL_INVESTIGATOR)
Maryland Vision InstituteHagerstownMaryland21740
Irina Price
Dr. Augustus "Gus" Stern (PRINCIPAL_INVESTIGATOR)
Vance Thompson Vision- AlexandriaAlexandriaMinnesota56308
Isaac McCoy
Dr. Deborah Ristvedt (PRINCIPAL_INVESTIGATOR)
Tekwani Vision CenterBay Saint LouisMississippi63128
Amber Putman
Dr. Navin Tekwani (PRINCIPAL_INVESTIGATOR)
Bergstrom Eye ResearchFargoNorth Dakota58103
Angela Callaghan
Dr. Lance Bergstrom (PRINCIPAL_INVESTIGATOR)
Vance Thompson Vision, NDWest FargoNorth Dakota58078
Sarah Thiede
Dr. Michael Greenwood (PRINCIPAL_INVESTIGATOR)
Northeastern Eye InstituteScrantonPennsylvania18503
Patti Myers
Dr. William Jordan Jr. (PRINCIPAL_INVESTIGATOR)
Conway OphthalmologyConwaySouth Carolina29526
Rebecca Thigpen
Dr. Charles Proctor (PRINCIPAL_INVESTIGATOR)
Vance Thompson VisionSioux FallsSouth Dakota57108
Jason Meyer
Dr. Daniel Terveen (PRINCIPAL_INVESTIGATOR)
Utah Eye Centers- Pleasant GrovePleasant GroveUtah84062
Rachel Buchanan
Dr. David Griffin (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chico, CA

By research site
Ridge Eye Care, Inc.· Chico, CAIcon Eye Care· Grand Junction, COLevenson Eye Associates· Jacksonville, FLMaryland Vision Institute· Hagerstown, MDVance Thompson Vision- Alexandria· Alexandria, MNTekwani Vision Center· Bay Saint Louis, MS

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