Back to resultsAssessment of the Safety and Efficacy of BRM424 Ophthalmic Solutions in Patients With Neurotrophic Keratitis
Primary Purpose
Neurotrophic Keratitis
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
BRM424 Ophthalmic Solution
Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Neurotrophic Keratitis
Eligibility Criteria
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;
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
BRM424 Ophthalmic Solution
Vehicle
Arm Description
Outcomes
Primary Outcome Measures
Percentage of patients achieving complete healing of the PED or corneal ulcer determined by corneal fluorescein staining
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05927428
Brief Title
Assessment of the Safety and Efficacy of BRM424 Ophthalmic Solutions in Patients With Neurotrophic Keratitis
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)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 30, 2023 (Anticipated)
Primary Completion Date
January 30, 2025 (Anticipated)
Study Completion Date
May 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BRIM Biotechnology Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The objective of this study is to compare the safety and efficacy of BRM424 OS compared to vehicle in patients with neurotrophic keratitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurotrophic Keratitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Double Masking
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BRM424 Ophthalmic Solution
Arm Type
Active Comparator
Arm Title
Vehicle
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
BRM424 Ophthalmic Solution
Intervention Description
A topical drop of BRM424 ophthalmic solution.
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
A topical drop of vehicle (minus active) ophthalmic solution.
Primary Outcome Measure Information:
Title
Percentage of patients achieving complete healing of the PED or corneal ulcer determined by corneal fluorescein staining
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
12. IPD Sharing Statement
Learn more about this trial
Assessment of the Safety and Efficacy of BRM424 Ophthalmic Solutions in Patients With Neurotrophic Keratitis
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