NCT05927428 · BRIM Biotechnology Inc.
Assessment of the Initial Efficacy and Safety of BRM424 Ophthalmic Solutions in Patients With Neurotrophic Keratitis
What this study is about
The objective of this study is to obtain initial effectiveness of BRM424 in patients with Stage 2 and Stage 3 NK and evaluate safety and how well patients handle the treatment.
View original scientific description
The objective of this study is to obtain initial efficacy of BRM424 in patients with Stage 2 and Stage 3 NK and evaluate safety and tolerability.
Interventions
DRUG
BRM424 Ophthalmic Solution - Dose1
A topical drop of BRM424 ophthalmic solution.
DRUG
BRM424 Ophthalmic Solution - Dose2
A topical drop of BRM424 ophthalmic solution.
Primary outcome measures
Proportion of patients achieving complete healing of the PED or corneal ulcer determined by corneal fluorescein staining
Time frame: at or before 4 weeks
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Be at least 18 years of age;
- Provide written informed consent;
- Patients with NK Stage 2 (PED) or Stage 3 (corneal ulcer);
Exclusion criteria
- Any active ocular infection (bacterial, viral, fungal or protozoal) or active ocular inflammation not related to NK;
- Anticipated need to use therapeutic contact lenses or contact lens wear for refractive correction during the 28-days Treatment Period in the eye(s) with NK;
- Be a woman of childbearing potential who is not using an acceptable means of birth control;
Where
- Leland, North Carolina
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 28, 2024 · Source of record for eligibility and locations