NCT05927428

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2024

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 3, 2023

Completed
1.1 years until next milestone

Study Start

First participant enrolled

July 31, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
Last Updated

October 28, 2024

Status Verified

October 1, 2024

Enrollment Period

1.1 years

First QC Date

May 31, 2023

Last Update Submit

October 24, 2024

Conditions

Neurotrophic Keratitis

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients achieving complete healing of the PED or corneal ulcer determined by corneal fluorescein staining

    at or before 4 weeks

Study Arms (2)

BRM424 Ophthalmic Solution - Dose1

ACTIVE COMPARATOR
Drug: BRM424 Ophthalmic Solution - Dose1

BRM424 Ophthalmic Solution - Dose2

ACTIVE COMPARATOR
Drug: BRM424 Ophthalmic Solution - Dose2

Interventions

BRM424 Ophthalmic Solution - Dose1DRUG

A topical drop of BRM424 ophthalmic solution.

BRM424 Ophthalmic Solution - Dose1
BRM424 Ophthalmic Solution - Dose2DRUG

A topical drop of BRM424 ophthalmic solution.

BRM424 Ophthalmic Solution - Dose2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be at least 18 years of age;
  • Provide written informed consent;
  • Patients with NK Stage 2 (PED) or Stage 3 (corneal ulcer);

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wilmington Eye

Leland, North Carolina, 28451, United States

RECRUITING

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Open-label, Randomized Study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2023

First Posted

July 3, 2023

Study Start

July 31, 2024

Primary Completion

August 30, 2025

Study Completion

November 30, 2025

Last Updated

October 28, 2024

Record last verified: 2024-10

Locations

US(1)