Neurotrophic KeratitisPhase 2NCT05927428
Assessment of the Initial Efficacy and Safety of BRM424 Ophthalmic Solutions in Patients With Neurotrophic Keratitis
A Phase 2 study testing BRM424 Ophthalmic Solution - Dose1 and BRM424 Ophthalmic Solution - Dose2 in people with Neurotrophic Keratitis, run by BRIM Biotechnology Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurotrophic Keratitis
- What is being tested?
- BRM424 Ophthalmic Solution - Dose1 and BRM424 Ophthalmic Solution - Dose2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2024to 30 Nov 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be at least 18 years of age;
- Provide written informed consent;
- Patients with NK Stage 2 (PED) or Stage 3 (corneal ulcer);
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Wilmington Eye
Leland, North Carolina, 28451
Crystal Wong, 910-763-3601, cwong@wilmingtoneye.co
About this study
Official title: An Open-Label, Multi-Center, Phase 2 Dose Ranging Study of BRM424 Ophthalmic Solution in Patients With Neurotrophic Keratitis (NK)
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.
- Conditions
- Neurotrophic Keratitis
- Being tested
- BRM424 Ophthalmic Solution - Dose1, BRM424 Ophthalmic Solution - Dose2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BRM424 Ophthalmic Solution - Dose1Drug
A topical drop of BRM424 ophthalmic solution.
BRM424 Ophthalmic Solution - Dose2Drug
A topical drop of BRM424 ophthalmic solution.
| Study group | Role | What they receive |
|---|---|---|
| BRM424 Ophthalmic Solution - Dose1 | Active comparator | Not described Receives: Drug: BRM424 Ophthalmic Solution - Dose1 |
| BRM424 Ophthalmic Solution - Dose2 | Active comparator | Not described Receives: Drug: BRM424 Ophthalmic Solution - Dose2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients achieving complete healing of the PED or corneal ulcer determined by corneal fluorescein staining
Measured: at or before 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start31 Jul 2024
- Primary completion30 Aug 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurotrophic KeratitisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open-label, Randomized Study
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BRIM Biotechnology Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05927428
- Sponsor's protocol ID
- BRM424-21-C001
- Status last verified
- Oct 2024
- First submitted
- 31 May 2023
- Last updated
- 28 Oct 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multi-Center, Phase 2 Dose Ranging Study of BRM424 Ophthalmic Solution in Patients With Neurotrophic Keratitis (NK)
- ClinicalTrials.gov ID
- NCT05927428
- Acronym / sponsor ID
- BRM424-21-C001
- Conditions
- Neurotrophic Keratitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- BRIM Biotechnology Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Jul 2024 (actual)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 3 Jul 2023 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-label, Randomized Study
| Arm | Type | Receives |
|---|---|---|
| BRM424 Ophthalmic Solution - Dose1 | Active comparator | Drug: BRM424 Ophthalmic Solution - Dose1 |
| BRM424 Ophthalmic Solution - Dose2 | Active comparator | Drug: BRM424 Ophthalmic Solution - Dose2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Be at least 18 years of age;
- Provide written informed consent;
- Patients with NK Stage 2 (PED) or Stage 3 (corneal ulcer);
Key exclusion criteria (3 listed)
- 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;
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 |
|---|---|---|
| BRM424 Ophthalmic Solution - Dose1A topical drop of BRM424 ophthalmic solution. | Drug | BRM424 Ophthalmic Solution - Dose1 |
| BRM424 Ophthalmic Solution - Dose2A topical drop of BRM424 ophthalmic solution. | Drug | BRM424 Ophthalmic Solution - Dose2 |
Primary outcome
Proportion of patients achieving complete healing of the PED or corneal ulcer determined by corneal fluorescein staining
Time frame: at or before 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BRM424 Ophthalmic Solution - Dose1 and BRM424 Ophthalmic Solution - Dose2 in people with Neurotrophic Keratitis, run by BRIM Biotechnology Inc. at 1 site 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 28 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients achieving complete healing of the PED or corneal ulcer determined by corneal fluorescein staining (time frame: at or before 4 weeks). 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 28 Oct 2024.