A Study to Evaluate Efficacy and Safety of MELT-300 for Procedural Sedation in Subjects Undergoing Cataract Extraction With Lens Replacement (CELR)
Public ClinicalTrials.gov record NCT06383273. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group, Multi-Center Study to Evaluate Efficacy and Safety of MELT-300 for Procedural Sedation in Subjects Undergoing Cataract Extraction With Lens Replacement (CELR)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06383273
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 528 participants
Conditions and interventions
Conditions
Interventions
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 30, 2024
- Primary completion
- Nov 30, 2024
- Completion
- Dec 31, 2024
- Last update posted
- Aug 1, 2024
2024 – 2025
United States locations
- U.S. sites
- 12
- U.S. states
- 11
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Ridge Eye Care, Inc. | Chico | California | 95928 | Recruiting |
| Icon Eye Care | Grand Junction | Colorado | 81501 | Recruiting |
| Levenson Eye Associates | Jacksonville | Florida | 32204 | Recruiting |
| Maryland Vision Institute | Hagerstown | Maryland | 21740 | Recruiting |
| Vance Thompson Vision- Alexandria | Alexandria | Minnesota | 56308 | Recruiting |
| Tekwani Vision Center | Bay Saint Louis | Mississippi | 63128 | Recruiting |
| Bergstrom Eye Research | Fargo | North Dakota | 58103 | Recruiting |
| Vance Thompson Vision, ND | West Fargo | North Dakota | 58078 | Recruiting |
| Northeastern Eye Institute | Scranton | Pennsylvania | 18503 | Recruiting |
| Conway Ophthalmology | Conway | South Carolina | 29526 | Recruiting |
| Vance Thompson Vision | Sioux Falls | South Dakota | 57108 | Recruiting |
| Utah Eye Centers- Pleasant Grove | Pleasant Grove | Utah | 84062 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06383273, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 1, 2024 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06383273 live on ClinicalTrials.gov.