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Completed

NCT Number: NCT05695781

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

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.

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Key information

Conditions

Dry Eye Disease Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Andover Eye Associates

Warwick, Rhode Island, 02886, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

BRM421 Ophthalmic Solution

Drug

A topical drop of BRM421 ophthalmic solution.

Vehicle

Drug

A topical drop of vehicle (minus active) ophthalmic solution.

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

BRIM Biotechnology Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Jan 25, 2023
Registry last updated
Jul 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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