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

Part of paid clinical trials in Leland, North Carolina.

Sponsor
BRIM Biotechnology Inc.
Study ID
NCT05927428
Phase
PHASE2
Status
Recruiting
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Conditions

  • Neurotrophic Keratitis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BRM424 Ophthalmic Solution - Dose1 — DRUG
    A topical drop of BRM424 ophthalmic solution.
  • BRM424 Ophthalmic Solution - Dose2 — DRUG
    A topical drop of BRM424 ophthalmic solution.

Study Details

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.

Key Dates

Start date
Jul 31, 2024
Status verified
Oct 2024
Primary completion
Aug 30, 2025
Completion
Nov 30, 2025

Study Design

Enrollment
12 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: BRM424 Ophthalmic Solution - Dose1
  • Active Comparator: BRM424 Ophthalmic Solution - Dose2

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 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Wilmington EyeLelandNorth Carolina28451
Crystal Wong
[email protected]
910-763-3601

Find similar trials in Leland, NC

By research site
Wilmington Eye· Leland, NC

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