RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

An Open-Label, Multi-Center, Phase 2 Dose Ranging Study of BRM424 Ophthalmic Solution in Patients With Neurotrophic Keratitis (NK)

Quick Facts

Study Start:2024-07-31
Study Completion:2025-11-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05927428

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Be at least 18 years of age;
  2. * Provide written informed consent;
  3. * Patients with NK Stage 2 (PED) or Stage 3 (corneal ulcer);
  1. * Any active ocular infection (bacterial, viral, fungal or protozoal) or active ocular inflammation not related to NK;
  2. * 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;
  3. * Be a woman of childbearing potential who is not using an acceptable means of birth control;

Contacts and Locations

Study Locations (Sites)

Wilmington Eye
Leland, North Carolina, 28451
United States

Collaborators and Investigators

Sponsor: BRIM Biotechnology Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-31
Study Completion Date2025-11-30

Study Record Updates

Study Start Date2024-07-31
Study Completion Date2025-11-30

Terms related to this study

Additional Relevant MeSH Terms

  • Neurotrophic Keratitis