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

PHASE3RecruitingINTERVENTIONAL
Enrollment

528

Participants

Timeline

Start Date

May 1, 2024

Primary Completion Date

December 31, 2024

Study Completion Date

January 31, 2025

Conditions
Cataract
Interventions
DRUG

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.

DRUG

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.

DRUG

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.

Trial Locations (12)

18503

RECRUITING

Northeastern Eye Institute, Scranton

21740

RECRUITING

Maryland Vision Institute, Hagerstown

29526

RECRUITING

Conway Ophthalmology, Conway

32204

RECRUITING

Levenson Eye Associates, Jacksonville

56308

RECRUITING

Vance Thompson Vision- Alexandria, Alexandria

57108

RECRUITING

Vance Thompson Vision, Sioux Falls

58078

RECRUITING

Vance Thompson Vision, ND, West Fargo

58103

RECRUITING

Bergstrom Eye Research, Fargo

63128

RECRUITING

Tekwani Vision Center, Bay Saint Louis

81501

RECRUITING

Icon Eye Care, Grand Junction

84062

RECRUITING

Utah Eye Centers- Pleasant Grove, Pleasant Grove

95928

RECRUITING

Ridge Eye Care, Inc., Chico

All Listed Sponsors
collaborator

MedTrials Incorporated

UNKNOWN

collaborator

Evolution Research Group

NETWORK

collaborator

Catalent

INDUSTRY

collaborator

Pharmalex

UNKNOWN

lead

Melt Pharmaceuticals

INDUSTRY