RecruitingPhase 2NCT05927428
Assessment of the Initial Efficacy and Safety of BRM424 Ophthalmic Solutions in Patients With Neurotrophic Keratitis
An Open-Label, Multi-Center, Phase 2 Dose Ranging Study of BRM424 Ophthalmic Solution in Patients With Neurotrophic Keratitis (NK)
Sponsor
BRIM Biotechnology Inc.
Enrollment
12 participants
Start Date
Jul 31, 2024
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria3
- Be at least 18 years of age;
- Provide written informed consent;
- Patients with NK Stage 2 (PED) or Stage 3 (corneal ulcer);
Exclusion Criteria3
- 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;
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Interventions
DRUGBRM424 Ophthalmic Solution - Dose1
A topical drop of BRM424 ophthalmic solution.
DRUGBRM424 Ophthalmic Solution - Dose2
A topical drop of BRM424 ophthalmic solution.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05927428
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