CataractPhase 2NCT05133518
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)
A Phase 2 study testing MELT-300, Midazolam alone and Ketamine alone in people with Cataract, run by Melt Pharmaceuticals at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- MELT-300, Midazolam alone and Ketamine alone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 338 participants
- Where
- 3 sitesUnited States
- Study dates
- 20 Jul 2021to 3 Nov 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Are to undergo unilateral primary uncomplicated CELR under topical anesthesia, with a phacoemulsification device and insertion of an intraocular lens.
Who cannot join
- Participants scheduled for simultaneous bilateral or 2nd-eye cataract surgery (note, subjects scheduled for a future 2nd eye cataract study are eligible for the study).
- Known sensitivity to benzodiazepines or ketamine.
- Known sensitivity to -caines (including proparacaine), benzalkonium chloride (BAK).
- Intraocular pressure (IOP) ≥ 23 mmHg in the study eye and/or ≥ 30 mmHg in the fellow eye at screening. This IOP exclusion requirement will only need to be re-confirmed on the day of surgery if it has been > 14 days since the screening visit.
- History of iritis, or any ocular trauma with iris damage in the study eye.
- Presence of active corneal pathology other than corneal pathology per slit lamp and an external eye exam at screening in either eye.
Show all 18Show fewer
- Presence of extraocular/intraocular inflammation in either eye.
- Presence of active bacterial and/or viral infection in either eye.
- History of intraocular non-laser surgery in the study eye within the 3 months prior to day of surgery, or intraocular laser surgery in the study eye within 30 days prior to the day of surgery.
- Require or are planning other additional ocular surgery during the cataract surgery.
- 12. Have a history or clinical manifestations (e.g., signs, symptoms, laboratory values, diagnostic imaging, etc.) of significant gastrointestinal, cardiovascular, hepatic, renal, hematological, endocrine, neurological, psychiatric, respiratory, or other medical condition that in the opinion of the investigator might confound the study results or pose additional risk in administering the study procedures.
- 13. History of or presence of any connective tissue disorder (i.e., lupus, rheumatoid arthritis, fibromyalgia).
- 14. Use of disallowed medications, including the following:
- Pain medication (opioids, non-steroidal anti-inflammatory drugs [NSAIDs], cyclooxygenase-2 [COX-2] inhibitors, tramadol, ketamine, clonidine, gabapentin, pregabalin, or cannabinoids) within 3 days prior to Day 1, or routine, daily opioid therapy within the past 30 days.
- Central nervous system (CNS) active drugs such as benzodiazepines, tricyclic antidepressants, serotonin, and norepinephrine reuptake inhibitors (SNRIs), or selective serotonin reuptake inhibitors (SSRIs) for pain within 7 days prior to Day 1. These drugs are permitted for non-pain indications if the dose has been stable for at least 30 days prior to Day 1 and is planned to remain stable throughout the study. The use of lorazepam and other sleep medications, except those containing analgesic properties, is permitted.
- Use of parenteral or oral corticosteroid(s) within 14 days prior to Day 1.
- Antihypertensive agent or diabetic regimen at a dose that has not been stable for at least 30 days, or which is not expected to remain stable throughout the study.
- 15. Chronic pain rated moderate to severe within the past week (4-pt categorical scale, 0=no pain, 1=mild pain, 2=moderate pain, 3=severe pain). 17. Hospital Depression and Anxiety Scale (HADS) score > 10
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Levenson Eye Associates
Jacksonville, Florida, 32204
Martel Eye Medical Group
Rancho Cordova, California, 95670
Vance Thompson Vision
West Fargo, North Dakota, 58078
About this study
Official title: A Phase 2, Factorial-Designed, Randomized, Double-Blind, Placebo-Controlled, Parallel- Cohort Study to Evaluate Efficacy and Safety of MELT-300 and the Contribution of Midazolam and Ketamine Components to Sedation and Intraoperative Ocular Analgesia in Subjects Undergoing Cataract Extraction With Lens Replacement (CELR)
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.
Read the detailed description
This is a Phase 2, factorial-designed, randomized, double-blind, placebo-controlled, parallel-cohort study to be conducted in 324 adult male and female participants who are ≥ 55 years of age and undergoing cataract extraction with lens replacement. An additional 3 participants per site (first 3 participants enrolled per site) will be considered sentinel participants for the purpose of ensuring safety and that logistical and operational challenges that may occur during the study are identified and mitigated. Sentinel participants will be evaluated for safety but not for efficacy. The study aims to evaluate the efficacy and safety of MELT-300 and the contribution of midazolam and ketamine components for procedural sedation prior to cataract surgery. In the study, eligible study participants will be randomly assigned (1:1:1:1 ratio) to one of the following treatments: MELT-300 (3 mg/50 mg), midazolam 3 mg, ketamine 50 mg, and placebo sublingual tablet 30 (± 5) minutes prior to the anticipated start of surgery (defined as instillation of topical ocular anesthetic drops [i.e., proparacaine]) without food or water in the operating room. At the time of dosing, participants will be instructed to hold the tablet under their tongue until it is completely dissolved and to not swallow or chew the tablets. The study duration will be up to 35 days, including 28 days for screening and 7 ± 2 days after surgery.
Efficacy assessments will be performed after study medication administration before surgery, intraoperatively, and postoperatively on Day 1 (end of surgery defined as drape removal). Efficacy assessments will include assessments of sedation and intraoperative pain, the need for rescue medication for sedation or pain, and the ability to complete the surgery. Safety will be monitored at baseline, intraoperatively, postoperatively on Day 1, on the day after surgery (Day 2, via a phone call), and at 1 week (Day 8 ± 2 days) after dosing of study medication. Safety assessments will include monitoring of AEs, vital sign measurements, physical examinations, and 12-lead ECGs. Exploratory endpoints are postoperative pain as measured by the NPRS prior to discharge, 6 hours +/- 30 minutes after the end of surgery on Day 1 and on Days 2 (the day after surgery), the percentage of participants with concomitant medication opioid use, and average opioid consumption on Day 2 and participant likelihood of wanting study drug again for second cataract surgery as measured by an 11-point Likert scale on Day 2.
- Conditions
- Cataract
- Being tested
- MELT-300, Midazolam alone, Ketamine alone, Placebo
- Keywords
- Cataract surgery, Intraocular pressure, Intraoperative ocular pain, Sedation, Lens replacement, MELT-300, Cataract extraction
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MELT-300Drug
Sublingual tablet
Midazolam aloneDrug
Sublingual tablet
Ketamine aloneDrug
Sublingual tablet
PlaceboDrug
Sublingual tablet
| Study group | Role | What they receive |
|---|---|---|
| MELT-300 | Active comparator | Participants will receive a single dose of MELT-300 sublingual, rapidly dissolving tablet containing 3 mg of midazolam and 50 mg of ketamine. Receives: Drug: MELT-300 |
| Midazolam alone | Active comparator | Participants will receive a single dose of midazolam 3 mg sublingual tablet. Receives: Drug: Midazolam alone |
| Ketamine alone | Active comparator | Participants will receive a single dose of ketamine 50 mg sublingual tablet. Receives: Drug: Ketamine alone |
| Placebo | Placebo comparator | Participants will receive a single dose of a matching placebo sublingual tablet. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Success for Procedural Sedation by Using Ramsay Sedation Scale
The Ramsay Sedation Scale (RSS) was the first scale to be defined for the sedated participants and was designed as a test of arousability. The Ramsay Scale provides three levels of 'awake' states (score 1-3) and three levels of 'asleep' states (score 4-6). A score of 2 (participant is cooperative, orientated, and tranquil) best fits an optimum sedation level based on the criteria of calm, comfortable, communicative, and cooperative participants.
Ramsay Sedation Scale
- =Participant is anxious and agitated or restless, or both
- =Participant is cooperative, oriented, and tranquil
- =Participant responds to commands only
- =Participant exhibits brisk response to a light glabellar tap or loud auditory stimulus
- =Participant exhibits a sluggish response to a light glabellar tap or loud auditory stimulus
- =Participants exhibits no response RSS score will be assessed pre-operatively, intra-operatively, and post-operatively on Day 1
Measured: Day 1
Mean Intraoperative Analgesia as Measured by the Numeric Pain Rating Scale
The Numeric Pain Rating Scale (NPRS) is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
Measured: Intraoperatively on Day 1
Secondary outcomes (10)
Percentage of Pre-operative Target Sedation Responders by Ramsay Sedation Scale (level 2 or 3)
The Ramsay Sedation Scale (RSS) was the first scale to be defined for the sedated participants and was designed as a test of arousability. The Ramsay Scale provides three levels of 'awake' states (score 1-3) and three levels of 'asleep' states (score 4-6). A score of 2 (participant is cooperative, orientated, and tranquil) best fits an optimum sedation level based on the criteria of calm, comfortable, communicative, and cooperative participants.
Ramsay Sedation Scale
- =Participant is anxious and agitated or restless, or both
- =Participant is cooperative, oriented, and tranquil
- =Participant responds to commands only
- =Participant exhibits brisk response to a light glabellar tap or loud auditory stimulus
- =Participant exhibits a sluggish response to a light glabellar tap or loud auditory stimulus
- =Participants exhibits no response
Measured: Pre-operatively (at baseline), intra-operatively and post-operatively on Day 1
Percentage of Analgesia Responders Using Numeric Pain Rating Scale
The Numeric Pain Rating Scale (NPRS) is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
Measured: Pre-operatively (at baseline), intra-operatively and post-operatively on Day 1
Number of Participants with Sedation Scores
The Ramsay Sedation Scale (RSS) was the first scale to be defined for the sedated participants and was designed as a test of arousability. The Ramsay Scale provides three levels of 'awake' states (score 1-3) and three levels of 'asleep' states (score 4-6). A score of 2 (participant is cooperative, orientated, and tranquil) best fits an optimum sedation level based on the criteria of calm, comfortable, communicative, and cooperative participants.
Ramsay Sedation Scale
- =Participant is anxious and agitated or restless, or both
- =Participant is cooperative, oriented, and tranquil
- =Participant responds to commands only
- =Participant exhibits brisk response to a light glabellar tap or loud auditory stimulus
- =Participant exhibits a sluggish response to a light glabellar tap or loud auditory stimulus
- =Participants exhibits no response
Measured: After study medication administration before surgery (baseline), intraoperatively, and postoperatively on Day 1 (end of surgery defined as drape removal)
Number of Participants with Pain Scores
Measured: Before dosing on the day of surgery (Day 1)
Number of Participants-rated Worst Pain Following Completion of Surgery
Measured: Pre-operatively (at baseline), intra-operatively, and post-operatively on Day 1
Percentage of Participants Able to Complete Surgery
Measured: Pre-operatively (at baseline), intra-operatively and post-operatively on Day 1
Percentage of Participants Without Interruption of Surgery for Intervention (Other Than Rescue Medication) Due to Pain or Anxiety
Measured: Pre-operatively (at baseline), intra-operatively, and post-operatively on Day 1
Percentage of Participants Requiring Rescue Sedative Medication
The preoperative target level of sedation for this trial is Ramsay Sedation Scale (RSS) 2 or 3. If a participant does not achieve this level of sedation prior to the start of surgery (administration of topical local anesthesia), rescue sedation medication (i.e., intravenous midazolam only, at a dose determined by Investigator or anesthesiologist) may be given. Use of rescue sedation medication during surgery will be allowed if a participant's RSS score is <2.
Measured: Pre-operatively (at baseline) and Intra-operatively on Day 1
Percentage of Participants Requiring Rescue Analgesic Medication
Intraoperative pain assessments using the Numeric Pain Rating Scale (NPRS) scale, from 0 (no pain) to 10 (extreme pain), will be assessed.
The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
Measured: After study medication administration before surgery (baseline) and intraoperatively
Number of Participants Reported with At least One Treatment Emergent Adverse Event (TEAE)
A treatment-emergent adverse event is defined as any event not present prior to the initiation of the drug treatment or any event already present that worsens in either intensity or frequency following exposure to the drug treatment.
Measured: Pre-operatively (at baseline), intra-operatively post-operatively on Day 1, on the day after surgery (Day 2, via a phone call), and at 1 week (Day 8 ± 2 days) after dose of study medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start20 Jul 2021
- Primary completion26 Oct 2022
- Study completion3 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Factorial-designed, randomized, double-blind, placebo-controlled, parallel-cohort safety and efficacy study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 338 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melt Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Worldwide Clinical Trials
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05133518
- Sponsor's protocol ID
- MELT-2-001
- Status last verified
- Dec 2022
- First submitted
- 12 Nov 2021
- Last updated
- 19 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Factorial-Designed, Randomized, Double-Blind, Placebo-Controlled, Parallel- Cohort Study to Evaluate Efficacy and Safety of MELT-300 and the Contribution of Midazolam and Ketamine Components to Sedation and Intraoperative Ocular Analgesia in Subjects Undergoing Cataract Extraction With Lens Replacement (CELR)
- ClinicalTrials.gov ID
- NCT05133518
- Acronym / sponsor ID
- MELT-2-001
- Conditions
- Cataract
- Keywords
- Cataract surgery, Intraocular pressure, Intraoperative ocular pain, Sedation, Lens replacement, MELT-300, Cataract extraction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 338 participants (actual)
- Lead sponsor
- Melt PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Worldwide Clinical Trials
- Study start
- 20 Jul 2021 (actual)
- Primary completion
- 26 Oct 2022 (actual)
- Study completion
- 3 Nov 2022 (actual)
- First posted
- 24 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a Phase 2, factorial-designed, randomized, double-blind, placebo-controlled, parallel-cohort study to be conducted in 324 adult male and female participants who are ≥ 55 years of age and undergoing cataract extraction with lens replacement. An additional 3 participants per site (first 3 participants enrolled per site) will be considered sentinel participants for the purpose of ensuring safety and that logistical and operational challenges that may occur during the study are identified and mitigated. Sentinel participants will be evaluated for safety but not for efficacy. The study aims to evaluate the efficacy and safety of MELT-300 and the contribution of midazolam and ketamine components for procedural sedation prior to cataract surgery. In the study, eligible study participants will be randomly assigned (1:1:1:1 ratio) to one of the following treatments: MELT-300 (3 mg/50 mg), midazolam 3 mg, ketamine 50 mg, and placebo sublingual tablet 30 (± 5) minutes prior to the anticipated start of surgery (defined as instillation of topical ocular anesthetic drops [i.e., proparacaine]) without food or water in the operating room. At the time of dosing, participants will be instructed to hold the tablet under their tongue until it is completely dissolved and to not swallow or chew the tablets. The study duration will be up to 35 days, including 28 days for screening and 7 ± 2 days after surgery.
Efficacy assessments will be performed after study medication administration before surgery, intraoperatively, and postoperatively on Day 1 (end of surgery defined as drape removal). Efficacy assessments will include assessments of sedation and intraoperative pain, the need for rescue medication for sedation or pain, and the ability to complete the surgery. Safety will be monitored at baseline, intraoperatively, postoperatively on Day 1, on the day after surgery (Day 2, via a phone call), and at 1 week (Day 8 ± 2 days) after dosing of study medication. Safety assessments will include monitoring of AEs, vital sign measurements, physical examinations, and 12-lead ECGs. Exploratory endpoints are postoperative pain as measured by the NPRS prior to discharge, 6 hours +/- 30 minutes after the end of surgery on Day 1 and on Days 2 (the day after surgery), the percentage of participants with concomitant medication opioid use, and average opioid consumption on Day 2 and participant likelihood of wanting study drug again for second cataract surgery as measured by an 11-point Likert scale on Day 2.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Factorial-designed, randomized, double-blind, placebo-controlled, parallel-cohort safety and efficacy study.
| Arm | Type | Receives |
|---|---|---|
| MELT-300 | Active comparator | Drug: MELT-300Participants will receive a single dose of MELT-300 sublingual, rapidly dissolving tablet containing 3 mg of midazolam and 50 mg of ketamine. |
| Midazolam alone | Active comparator | Drug: Midazolam aloneParticipants will receive a single dose of midazolam 3 mg sublingual tablet. |
| Ketamine alone | Active comparator | Drug: Ketamine aloneParticipants will receive a single dose of ketamine 50 mg sublingual tablet. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive a single dose of a matching placebo sublingual tablet. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Are to undergo unilateral primary uncomplicated CELR under topical anesthesia, with a phacoemulsification device and insertion of an intraocular lens.
Key exclusion criteria (18 listed)
- Participants scheduled for simultaneous bilateral or 2nd-eye cataract surgery (note, subjects scheduled for a future 2nd eye cataract study are eligible for the study).
- Known sensitivity to benzodiazepines or ketamine.
- Known sensitivity to -caines (including proparacaine), benzalkonium chloride (BAK).
- Intraocular pressure (IOP) ≥ 23 mmHg in the study eye and/or ≥ 30 mmHg in the fellow eye at screening. This IOP exclusion requirement will only need to be re-confirmed on the day of surgery if it has been > 14 days since the screening visit.
- History of iritis, or any ocular trauma with iris damage in the study eye.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MELT-300Sublingual tablet | Drug | MELT-300 |
| Midazolam aloneSublingual tablet | Drug | Midazolam alone |
| Ketamine aloneSublingual tablet | Drug | Ketamine alone |
| PlaceboSublingual tablet | Drug | Placebo |
Primary outcome
Percentage of Participants with Success for Procedural Sedation by Using Ramsay Sedation Scale
Time frame: Day 1
The Ramsay Sedation Scale (RSS) was the first scale to be defined for the sedated participants and was designed as a test of arousability. The Ramsay Scale provides three levels of 'awake' states (score 1-3) and three levels of 'asleep' states (score 4-6). A score of 2 (participant is cooperative, orientated, and tranquil) best fits an optimum sedation level based on the criteria of calm, comfortable, communicative, and cooperative participants. Ramsay Sedation Scale 1. =Participant is anxious and agitated or restless, or both 2. =Participant is cooperative, oriented, and tranquil 3. =Participant responds to commands only 4. =Participant exhibits brisk response to a light glabellar tap or loud auditory stimulus 5. =Participant exhibits a sluggish response to a light glabellar tap or loud auditory stimulus 6. =Participants exhibits no response RSS score will be assessed pre-operatively, intra-operatively, and post-operatively on Day 1
Mean Intraoperative Analgesia as Measured by the Numeric Pain Rating Scale
Time frame: Intraoperatively on Day 1
The Numeric Pain Rating Scale (NPRS) is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
10 secondary outcomes
Percentage of Pre-operative Target Sedation Responders by Ramsay Sedation Scale (level 2 or 3)
Time frame: Pre-operatively (at baseline), intra-operatively and post-operatively on Day 1
Percentage of Analgesia Responders Using Numeric Pain Rating Scale
Time frame: Pre-operatively (at baseline), intra-operatively and post-operatively on Day 1
Number of Participants with Sedation Scores
Time frame: After study medication administration before surgery (baseline), intraoperatively, and postoperatively on Day 1 (end of surgery defined as drape removal)
Number of Participants with Pain Scores
Time frame: Before dosing on the day of surgery (Day 1)
Number of Participants-rated Worst Pain Following Completion of Surgery
Time frame: Pre-operatively (at baseline), intra-operatively, and post-operatively on Day 1
Percentage of Participants Able to Complete Surgery
Time frame: Pre-operatively (at baseline), intra-operatively and post-operatively on Day 1
Percentage of Participants Without Interruption of Surgery for Intervention (Other Than Rescue Medication) Due to Pain or Anxiety
Time frame: Pre-operatively (at baseline), intra-operatively, and post-operatively on Day 1
Percentage of Participants Requiring Rescue Sedative Medication
Time frame: Pre-operatively (at baseline) and Intra-operatively on Day 1
Percentage of Participants Requiring Rescue Analgesic Medication
Time frame: After study medication administration before surgery (baseline) and intraoperatively
Number of Participants Reported with At least One Treatment Emergent Adverse Event (TEAE)
Time frame: Pre-operatively (at baseline), intra-operatively post-operatively on Day 1, on the day after surgery (Day 2, via a phone call), and at 1 week (Day 8 ± 2 days) after dose of study medication
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MELT-300, Midazolam alone and Ketamine alone in people with Cataract, run by Melt Pharmaceuticals at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants with Success for Procedural Sedation by Using Ramsay Sedation Scale (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2022.