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Tests treatment safety and results for Cataract
Official title A Study to Evaluate Efficacy and Safety of MELT-300 for Procedural Sedation in Subjects Undergoing Cataract Extraction With Lens Replacement (CELR)
ClinicalTrials.gov ID: NCT06383273
What this study is testing
What is MELT-300 sublingual tablet?
MELT-300 sublingual tablet is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for cataract.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Participants must meet all of the following in order to be enrolled into the study:
- Males and females ≥ 18 years of age
- Are to undergo unilateral primary CELR under topical anesthesia, with a phacoemulsification device and insertion of an intraocular lens (no...
- For women of childbearing potential (WOCBP), have a negative urine pregnancy test, and abstain from sexual activity or use a double barrier method...
- Willing to refrain from alcohol consumption within 24 hours of randomization
You likely can't join if
- people scheduled for simultaneous bilateral or 2nd-eye cataract surgery (people scheduled for a future 2nd eye cataract surgery are eligible for the...
- Known sensitivity to benzodiazepines or ketamine
- Known sensitivity to -caines (including proparacaine, ester-type local anesthetics), benzalkonium chloride (BAK)
- Intraocular pressure (IOP) \> 30 mmHg in the study eye or fellow eye at screening.
- History of iritis, or any ocular trauma with iris damage in the study eye
- Presence of active corneal pathology other than dry eye per slit lamp and external eye exam at screening in either eye
See the full eligibility criteria
- Participants must meet all of the following in order to be enrolled into the study:
- Males and females ≥ 18 years of age
- Are to undergo unilateral primary CELR under topical anesthesia, with a phacoemulsification device and insertion of an intraocular lens (no restrictions on lens type)
- For women of childbearing potential (WOCBP), have a negative urine pregnancy test, and abstain from sexual activity or use a double barrier method (e.g. condom and diaphragm) of birth control from Day 1 and up to 2 days...
- Willing to refrain from alcohol consumption within 24 hours of randomization
- Are competent to provide informed consent
- Voluntarily provide informed consent in accordance with governing International Review Board (IRB) requirements and provide Health Insurance Portability and Accountability Act (HIPAA) authorization, prior to any...
- Indicate they understand and are able, willing, and likely to fully comply with study procedures and restrictions
- people scheduled for simultaneous bilateral or 2nd-eye cataract surgery (people scheduled for a future 2nd eye cataract surgery are eligible for the study)
- Known sensitivity to benzodiazepines or ketamine
- Known sensitivity to -caines (including proparacaine, ester-type local anesthetics), benzalkonium chloride (BAK)
- Intraocular pressure (IOP) \> 30 mmHg in the study eye or fellow eye at screening.
- History of iritis, or any ocular trauma with iris damage in the study eye
- Presence of active corneal pathology other than dry eye per slit lamp and external eye exam at screening in either eye
- 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
- Requiring or planning other additional ocular surgery during the cataract surgery (e.g. glaucoma surgery ([minimally invasive or traditional], limbal relaxing incisions, etc.) or performing laser-assisted CELR
- Presence of active infection, mucositis, cold sores, canker sores, vesicles, viral lesions, local irritation/inflammation, or periodontal disease of the oral cavity. In addition, evidence of piercings of the tongue or...
- Women who are nursing a child or plan to nurse a child during the study
- Have a history or clinical manifestations (e.g., signs, symptoms, laboratory values, diagnostic imaging, etc.) of significant gastrointestinal, cardiovascular, hepatic, renal, hematological, endocrine, neurological...
- Use of disallowed medications including the following:
- Antihypertensive agent or diabetic regimen at a dose that has not been stable for at least 30 days prior to Day 1, or which is not expected to remain stable throughout the study
- Central nervous system (CNS) active drugs such as benzodiazepines, tricyclic antidepressants, serotonin and norepinephrine reuptake inhibitors (SNRIs), or selective serotonin reuptake inhibitors (SSRIs) that have not...
- Initiating the use of, switching to a different, or increasing the dose of a sleep medication (e.g. lorazepam, zolpidem, etc) within 3 days of randomization
- Illicit drug use or alcohol abuse based on medical history, or currently engaged in illicit drug use or alcohol abuse.
- Alcohol abuse is defined as 5 or more drinks in one sitting or 15 or more drinks in a week for men and 4 or more drinks in one sitting or 8 or more drinks in a week for women. A drink is considered a 1.5 oz shot, 12 oz...
- However, patients with a medical history of illicit drug use or alcohol abuse ≥ 5 years prior to the time of screening and who have recovered and have been drug/alcohol free for at least that period of time (i.e., 5...
- Creatinine clearance rate \< 60 mL/min estimated using the CKD-EPI 2021cr (NKD) equation
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase (ALP) \> 2.5 times upper limit of normal (ULN), or total bilirubin \> 1.5 x ULN. In cases of documented Gilbert syndrome, people...
- Any other abnormal laboratory results or presence of any condition that the Investigator believes would put the subject at risk or confound the interpretation of results
The study team makes the final eligibility decision.
Where it's taking place
- Chico, California, United States
- Grand Junction, Colorado, United States
- Jacksonville, Florida, United States
- Hagerstown, Maryland, United States
- Alexandria, Minnesota, United States
- Bay Saint Louis, Mississippi, United States
- Fargo, North Dakota, United States
- West Fargo, North Dakota, United States
- Scranton, Pennsylvania, United States
- Conway, South Carolina, United States
- Sioux Falls, South Dakota, United States
- Pleasant Grove, Utah, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chico, California, United States; Grand Junction, Colorado, United States; Jacksonville, Florida, United States; Hagerstown, Maryland, United States; Alexandria, Minnesota, United States; Bay Saint Louis, Mississippi, United States and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.