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A Study of MELT-300 (Midazolam and Ketamine Sublingual Tablets) for Sedation and Intraoperative Ocular Analgesia in Participants Undergoing Cataract Extraction With Lens Replacement (CELR)

NCT05133518 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 338

Last updated 2022-12-19

No results posted yet for this study

Summary

The primary purpose of the study is to evaluate the efficacy and safety of MELT-300 (Midazolam and Ketamine Sublingual Tablets) and the contribution of midazolam and ketamine components to sedation and during the surgery or ocular analgesia in participants undergoing cataract surgery with lens replacement.

Conditions

  • Cataract

Interventions

DRUG

MELT-300

Sublingual tablet

DRUG

Midazolam alone

Sublingual tablet

DRUG

Ketamine alone

Sublingual tablet

DRUG

Placebo

Sublingual tablet

Sponsors & Collaborators

  • Worldwide Clinical Trials

    collaborator OTHER

  • Melt Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-20
Primary Completion
2022-10-26
Completion
2022-11-03
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05133518 on ClinicalTrials.gov