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CompletedNCT05695781Updated Jul 11, 2024

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

A Phase 3 interventional study of BRM421 Ophthalmic Solution and Vehicle in Dry Eye Disease, sponsored by BRIM Biotechnology Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-11.

Sponsored by BRIM Biotechnology Inc. · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Dec 2023, 2 years 9 months ago, and no results have been posted to the registry.
Phase
Phase 3
Study type
Interventional
Enrollment
740
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Dry Eye Disease
03

In context

Dry Eye Syndromes

1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.

This study's enrollment of 740 is above the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.

Browse Dry Eye Syndromes studies →

Lead sponsor

BRIM Biotechnology Inc. is the lead sponsor of 6 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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;
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
740 participants (actual)

Study arms

  • Active comparator
    BRM421 Ophthalmic Solution

    Drug: BRM421 Ophthalmic Solution

  • Placebo comparator
    Vehicle

    Drug: Vehicle

Interventions

  • DrugBRM421 Ophthalmic Solution

    A topical drop of BRM421 ophthalmic solution.

  • DrugVehicle

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

06

What researchers measure

Primary outcomes

  1. Ocular Sign: Change From Baseline in Total Corneal Fluorescein Staining Score

    0-12 Ora scale, higher scores mean a worse outcome.

    Time frame: 1-2 weeks

  2. Ocular Symptom: Change From Baseline in Visual Analog Scale (VAS)

    0-100 Visual Analog Scale, higher scores mean a worse discomfort.

    Time frame: 1-2 weeks

07

Study locations

1 site
  • Andover Eye Associates
    Warwick, Rhode Island 02886, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 11, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05695781
Lead sponsor
BRIM Biotechnology Inc.
Responsible party
Sponsor
First posted
Jan 25, 2023
Start date
Feb 27, 2023
Primary completion
Dec 30, 2023
Completion
Mar 30, 2024
Last update
Jul 11, 2024

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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