protocolSection identificationModule nctId: NCT06383273, orgStudyIdInfo id: MELT-3-001, briefTitle: A Study to Evaluate Efficacy and Safety of MELT-300 for Procedural Sedation in Subjects Undergoing Cataract Extraction With Lens Replacement (CELR), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-01, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Melt Pharmaceuticals, class: INDUSTRY, collaborators name: MedTrials Incorporated, collaborators name: Evolution Research Group, collaborators name: Catalent, collaborators name: Pharmalex, descriptionModule briefSummary: 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-3004. What medical problems do participants have when taking MELT-300 vs placeboEligible participants will admitted to the study unit on Day 1. Participants will be randomized prior to surgery 4:1:1 to1. 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., conditionsModule conditions: Cataract, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized, Double-Masked, Placebo-Controlled, Parallel-Group, Multi-Center Study, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Double-masked, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 486, type: ESTIMATED, armsInterventionsModule interventions name: MELT-300 sublingual tablet, interventions name: Midalozam sublingual tablet, interventions name: Placebo sublingual tablet, outcomesModule primaryOutcomes measure: Percentage of Participants Achieving Successful Procedural Sedation, secondaryOutcomes measure: Percentage of Participants Requiring Rescue Sedation Medication, secondaryOutcomes measure: Percentage of Participants Achieving Preoperative Procedural Sedation Without Need For Rescue Sedation Medication, secondaryOutcomes measure: Percentage of Participants Requiring Rescue Sedation Medication Preoperatively, secondaryOutcomes measure: Percentage of Participants Requiring Rescue Sedation Medication Intraoperatively, secondaryOutcomes measure: Assessment of Sedation Scores in Participants Without Requiring Rescue Sedation Medication, secondaryOutcomes measure: Percentage of Participants Able to Complete the Surgery, secondaryOutcomes measure: Percentage of Participants Able to Complete the Surgery Without Intervention (Other Than Rescue Sedation Medication), secondaryOutcomes measure: Duration to Achieve Preoperative Target Sedation (RSS level 2 or 3), secondaryOutcomes measure: Percentage of Participants Reporting Treatment Emergent Adverse Events (TEAEs), secondaryOutcomes measure: Percentage of Participants Reporting Adverse Events Special Interest (AESIs), secondaryOutcomes measure: Mean Change from Baseline in Blood Pressure (mmHg), secondaryOutcomes measure: Mean Change from Baseline in Heart Rate [beats per minute (bpm)], secondaryOutcomes measure: Mean Change from Baseline in Respiratory Rate (breath per minute), secondaryOutcomes measure: Mean Change from Baseline in Body Temperature (degrees Fahrenheit), secondaryOutcomes measure: Mean Change from Baseline in Pulse Oximetry (%), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False