Assessment of the Safety and Efficacy of BRM421 Ophthalmic Solutions in Dry Eye Subjects.

September 15, 2023 updated by: BRIM Biotechnology Inc.

A Multi-Center, Randomized, Double Masked, Vehicle Controlled Clinical Study to Assess the Safety and Efficacy of BRM421 Ophthalmic Solution in Subjects With Dry Eye Using a Controlled Adverse Environment (CAE®) Model

The objective of this study is to compare the safety and efficacy of BRM421 OS to vehicle for the treatment of the signs and symptoms of dry eye disease.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

732

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • Recruiting
        • Andover Eye Associates
        • Contact:
          • Alin Ning

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Be at least 18 years of age;
  • Provide written informed consent;
  • Have a reported history of dry eye prior to enrollment;
  • Have a history of use or desire to use eye drops;

Exclusion Criteria:

  • Have any clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters;
  • Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;
  • Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;
  • Have used any eye drops within 2 hours of Visit 1;
  • Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
  • Be a woman of childbearing potential who is not using an acceptable means of birth control;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Vehicle
Drug: Vehicle
A topical drop of vehicle (minus active) ophthalmic solution.
Active Comparator: BRM421 Ophthalmic Solution
Drug: BRM421 Ophthalmic Solution
A topical drop of BRM421 ophthalmic solution.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ocular Sign: Change From Baseline in Total Corneal Fluorescein Staining Score
Time Frame: 1-2 weeks
0-12 Ora scale, higher scores mean a worse outcome.
1-2 weeks
Ocular Symptom: Change From Baseline in Visual Analog Scale (VAS)
Time Frame: 1-2 weeks
0-100 Visual Analog Scale, higher scores mean a worse discomfort.
1-2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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 Major Dates

Study Start (Actual)

February 27, 2023

Primary Completion (Estimated)

December 30, 2023

Study Completion (Estimated)

March 30, 2024

Study Registration Dates

First Submitted

January 13, 2023

First Submitted That Met QC Criteria

January 13, 2023

First Posted (Actual)

January 25, 2023

Study Record Updates

Last Update Posted (Actual)

September 18, 2023

Last Update Submitted That Met QC Criteria

September 15, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRM421-22-C001-PR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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