Recruiting NCT05927428
Assessment of the Initial Efficacy and Safety of BRM424 Ophthalmic Solutions in Patients With Neurotrophic Keratitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BRM424 Ophthalmic Solution - Dose1, BRM424 Ophthalmic Solution - Dose2.
- Who it may be relevant to
- Registry conditions: Neurotrophic Keratitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Open-Label, Multi-Center, Phase 2 Dose Ranging Study of BRM424 Ophthalmic Solution in Patients With Neurotrophic Keratitis (NK)
Overview
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.
Interventions
- Drug BRM424 Ophthalmic Solution - Dose1
A topical drop of BRM424 ophthalmic solution. - Drug BRM424 Ophthalmic Solution - Dose2
A topical drop of BRM424 ophthalmic solution.
Primary outcome measures
- Proportion of patients achieving complete healing of the PED or corneal ulcer determined by corneal fluorescein staining [Time frame: at or before 4 weeks]
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;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Wilmington Eye — Leland
Identifiers
NCT: NCT05927428 · BRM424-21-C001