Safety and Efficacy of BRM421 for Dry Eye Syndrome Treatment

Last updated: September 24, 2021
Sponsor: BRIM Biotechnology Inc.
Overall Status: Completed

Phase

2/3

Condition

Dry Eyes

Eyelid Inflammation

Sjogren's Syndrome

Treatment

N/A

Clinical Study ID

NCT04343287
BRM421-18-C001-PR
  • Ages > 18
  • All Genders

Study Summary

The objective of this study is to compare the safety and efficacy of BRM421 Ophthalmic Solution to placebo for the treatment of the signs and symptoms of dry eye.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Be at least 18 years of age;
  • Provide written informed consent;
  • Have a reported history of dry eye for at least 6 months prior to enrollment;
  • Have a history of use of eye drops

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 220
Study Start date:
January 15, 2020
Estimated Completion Date:
June 23, 2020

Study Description

This is a multi-center, double-masked, randomized, placebo-controlled, phase 2/3 study with approximately 200 subjects. (around 100 subjects per treatment arm).

Connect with a study center

  • Eye Research Foundation

    Newport Beach, California 92663
    United States

    Site Not Available

  • Midwest Cornea Associates, LLC

    Indianapolis, Indiana 46290
    United States

    Site Not Available

  • Andover Eye Associates

    Andover, Massachusetts 01810
    United States

    Site Not Available

  • Total Eye Care

    Memphis, Tennessee 38119
    United States

    Site Not Available

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