528
Participants
Start Date
May 1, 2024
Primary Completion Date
December 31, 2024
Study Completion Date
January 31, 2025
MELT-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.
Midalozam 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.
Placebo 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.
RECRUITING
Northeastern Eye Institute, Scranton
RECRUITING
Maryland Vision Institute, Hagerstown
RECRUITING
Conway Ophthalmology, Conway
RECRUITING
Levenson Eye Associates, Jacksonville
RECRUITING
Vance Thompson Vision- Alexandria, Alexandria
RECRUITING
Vance Thompson Vision, Sioux Falls
RECRUITING
Vance Thompson Vision, ND, West Fargo
RECRUITING
Bergstrom Eye Research, Fargo
RECRUITING
Tekwani Vision Center, Bay Saint Louis
RECRUITING
Icon Eye Care, Grand Junction
RECRUITING
Utah Eye Centers- Pleasant Grove, Pleasant Grove
RECRUITING
Ridge Eye Care, Inc., Chico
Lead Sponsor
Collaborators (3)
MedTrials Incorporated
UNKNOWN
Evolution Research Group
NETWORK
Catalent
INDUSTRY
Pharmalex
UNKNOWN
Melt Pharmaceuticals
INDUSTRY