BRM424 Ophthalmic Solution for Neurotrophic Keratitis

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: BRIM Biotechnology Inc.

Disqualifiers: Active ocular infection, Contact lenses, Childbearing potential

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

12 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

How is the drug BRM424 Ophthalmic Solution different from other treatments for neurotrophic keratitis?

BRM424 Ophthalmic Solution may be unique due to its potential use of brimonidine tartrate, which is known for its neuroprotective properties and ability to improve ocular drug delivery, as seen in treatments for other eye conditions like glaucoma and choroidal neovascularization. This could offer a novel approach for treating neurotrophic keratitis by enhancing drug bioavailability and reducing the need for frequent administration. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adults over 18 with Stage 2 or Stage 3 Neurotrophic Keratitis, a condition affecting the cornea of the eye. Participants must be able to give informed consent. It's not specified who can't join, but typically those with conditions that could interfere with the study are excluded.

Inclusion Criteria

My eye condition is at stage 2 or 3.

Provide written informed consent

Exclusion Criteria

I do not have any active eye infections or inflammation unrelated to NK.

I am a woman who can have children and am not using birth control.

I will need to wear contact lenses for eye correction during the treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BRM424 Ophthalmic Solution to assess initial efficacy and safety in patients with Stage 2 and Stage 3 Neurotrophic Keratitis

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• BRM424 Ophthalmic Solution

Trial Overview The trial is testing two different doses of BRM424 Ophthalmic Solution to see how effective they are in treating Neurotrophic Keratitis and to check their safety and tolerability in patients.

Participant Groups

Group I: BRM424 Ophthalmic Solution - Dose1 Active Control 1 Intervention

Group II: BRM424 Ophthalmic Solution - Dose2 Active Control 1 Intervention

Who Is Running the Clinical Trial?

BRIM Biotechnology Inc.

Lead Sponsor

Trials

4

Recruited

1,100+

Findings from Research

Brimonidine tartrate ophthalmic solution 0.15% significantly improved low-contrast visual acuity and contrast sensitivity in patients experiencing night-vision difficulties after laser refractive surgery, with effects observed as soon as one hour after administration.

After one month of treatment, all six patients reported subjective improvements in their night vision, indicating that brimonidine tartrate can provide lasting benefits for up to a month post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of brimonidine tartrate 0.15% on night-vision difficulty and contrast testing after refractive surgery. Edwards, JD., Burka, JM., Bower, KS., et al.[2015]

Brimonidine tartrate (BRT) proniosomes were developed to enhance the stability and bioavailability of the drug for glaucoma treatment, achieving an entrapment efficiency of 79.23% and significantly improved drug release over 24 hours.

In vivo studies demonstrated that the proniosome formulation provided 5.024 times greater ocular bioavailability and 7.90 times longer mean residence time compared to the standard treatment, Alphagan®P, while also showing no ocular irritation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proniosomal gel-derived niosomes: an approach to sustain and improve the ocular delivery of brimonidine tartrate; formulation, in-vitro characterization, and in-vivo pharmacodynamic study. Emad Eldeeb, A., Salah, S., Ghorab, M.[2023]

In a study of 23 pediatric patients with refractory uveitis, biological response modifiers (BRM) showed promising results, with infliximab leading to a 77% improvement in visual acuity and a 77% reduction in inflammation.

BRM treatments were found to be safe for children and can serve as effective adjunctive therapies for managing difficult cases of childhood uveitis, with varying efficacy observed among different BRM agents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biological response modifier therapy for refractory childhood uveitis. Gallagher, M., Quinones, K., Cervantes-Castañeda, RA., et al.[2022]

In a pilot study involving 20 eyes, topical brimonidine 0.2% applied before laser treatment for choroidal neovascularization significantly improved visual outcomes compared to a placebo, with a P-value of 0.027.

The results suggest that brimonidine may protect the neuroretina from damage during laser treatment, highlighting its potential as a neuroprotective agent in eye care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical brimonidine reduces collateral damage caused by laser photocoagulation for choroidal neovascularization. Ferencz, JR., Gilady, G., Harel, O., et al.[2018]

Topical application of brimonidine tartrate 0.1% for one week resulted in significant concentrations of the drug in the vitreous (mean 4.8 nM) and aqueous humor (mean 336.0 nM) of patients undergoing eye surgery, indicating effective penetration of the medication.

The presence of brimonidine in the vitreous was observed in 79% of patients, and the concentration was sufficient to activate neuroprotective receptors, suggesting potential therapeutic benefits for retinal protection, regardless of whether the patients had natural or artificial lenses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vitreous and aqueous concentrations of brimonidine following topical application of brimonidine tartrate 0.1% ophthalmic solution in humans. Takamura, Y., Tomomatsu, T., Matsumura, T., et al.[2015]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effect of brimonidine tartrate 0.15% on night-vision difficulty and contrast testing after refractive surgery. [2015]

2. England pubmed.ncbi.nlm.nih.gov

Proniosomal gel-derived niosomes: an approach to sustain and improve the ocular delivery of brimonidine tartrate; formulation, in-vitro characterization, and in-vivo pharmacodynamic study. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Biological response modifier therapy for refractory childhood uveitis. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Topical brimonidine reduces collateral damage caused by laser photocoagulation for choroidal neovascularization. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Vitreous and aqueous concentrations of brimonidine following topical application of brimonidine tartrate 0.1% ophthalmic solution in humans. [2015]