Recruiting
Phase 2

BRM424

Sponsor:

BRIM Biotechnology Inc.

Code:

NCT05927428

Conditions

Neurotrophic Keratitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BRM424 Ophthalmic Solution - Dose1

BRM424 Ophthalmic Solution - Dose2

Study Details

Brief 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.

Conditions

Neurotrophic Keratitis

Study ID

NCT05927428

Start date

Jul 31, 2024

Status verified date

Oct, 2024

Completion date

Nov 30, 2025

Anticipated

Primary completion date

Aug 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

12 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: BRM424 Ophthalmic Solution - Dose1

active comparator: BRM424 Ophthalmic Solution - Dose2

Interventions

BRM424 Ophthalmic Solution - Dose1

A topical drop of BRM424 ophthalmic solution.

BRM424 Ophthalmic Solution - Dose2

A topical drop of BRM424 ophthalmic solution.

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 ]

Central Contacts and Locations

Locations

Wilmington Eye

Recruiting

Leland, North Carolina, United States, 28451

Contacts

Crystal Wong

910-763-3601cwong@wilmingtoneye.co

More Information

Sponsor

BRIM Biotechnology Inc.

Last update posted

Oct 28, 2024

Last verified

Oct, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by BRIM Biotechnology Inc. on 2024-10-28.