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NCT05927428 Clinical Trial

Assessment of the Safety and Efficacy of BRM424 Ophthalmic Solutions in Patients With Neurotrophic Keratitis

Neurotrophic Keratitis Clinical Trial

Official title:
A Double-Masked, Multi-Center, Randomized, Vehicle- Controlled, Phase II Trial of the Efficacy and Safety of BRM424 Ophthalmic Solution in Patients With Neurotrophic Keratitis (NK)

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05927428
Other study ID # BRM424-21-C001
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date September 30, 2023
Est. completion date May 30, 2025

Study information
Verified date June 2023
Source BRIM Biotechnology Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this study is to compare the safety and efficacy of BRM424 OS compared to vehicle in patients with neurotrophic keratitis.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 48
Est. completion date May 30, 2025
Est. primary completion date January 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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;

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• BRM424 Ophthalmic Solution
A topical drop of BRM424 ophthalmic solution.
• Vehicle
A topical drop of vehicle (minus active) ophthalmic solution.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
BRIM Biotechnology Inc.

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of patients achieving complete healing of the PED or corneal ulcer determined by corneal fluorescein staining 4 weeks
See also
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Recruiting NCT04573647 - OCT Evaluation of Neurotrophic Ulcer Following Treatment With Oxervate
Completed NCT04820010 - Topical Insulin - Utility and Results in Neurotrophic Keratopathy in Stages 2 and 3
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Terminated NCT05809245 - Corneal Neurotization as a Treatment for Neurotrophic Keratopathy N/A
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Terminated NCT03037450 - Miniinvasive Corneal Neurotization. A Pilot Study. N/A
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Not yet recruiting NCT02707120 - Efficacy and Safety of Plasma Rich in Growth Factors (PRGF-Endoret) Eye-drops in the Treatment of Neurotrophic Keratitis Phase 4
Completed NCT01756456 - Evaluation of Safety and Efficacy of rhNGF in Patients With Stage 2 and 3 Neurotrophic Keratitis. Phase 1/Phase 2
Completed NCT02227147 - Evaluation of Efficacy of 20 µg/ml rhNGF New Formulation (With Anti-oxidant) in Patients With Stage 2 and 3 NK Phase 2
Recruiting NCT05552261 - DEFENDO Long Term Follow-up Study in Stage 1 NK Patients
Recruiting NCT04909450 - Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Neurotrophic Keratitis Subjects Phase 1/Phase 2
Active, not recruiting NCT06411145 - Open-label Trial to Evaluate Efficacy and Safety of rhNGF on Corneal Thickness Via AS-OCT in Neurotrophic Keratitis Phase 4