Dry Eye SyndromePhase 2/3NCT04343287

Safety and Efficacy of BRM421 for Dry Eye Syndrome Treatment

A Phase 2/3 study testing BRM421 in people with Dry Eye Syndrome, run by BRIM Biotechnology Inc. at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Dry Eye Syndrome
What is being tested?: BRM421
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 220 participants
Where: 4 sitesUnited States
Study dates: 15 Jan 2020to 23 Jun 2020
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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; acceptable methods of contraception

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Andover Eye Associates
Andover, Massachusetts, 01810
Midwest Cornea Associates, LLC
Indianapolis, Indiana, 46290
Total Eye Care
Memphis, Tennessee, 38119
Eye Research Foundation
Newport Beach, California, 92663

Other trials in United States

About this study

Official title: A Multi-Center, Randomized, Double Masked, Placebo 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 Ophthalmic Solution to placebo for the treatment of the signs and symptoms of dry eye.

Read the detailed 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).

Conditions: Dry Eye Syndrome
Being tested: BRM421, Placebo
Medical subject headings: Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BRM421Drug
The active control with BRM421 solution
PlaceboDrug
The vehicle solution

Study groups in NCT04343287
Study group	Role	What they receive
BRM421 Ophthalmic Solution	Active comparator	A topical solution of BRIM421 ophthalmic drops Receives: Drug: BRM421
Placebo	Placebo comparator	A vehicle ophthalmic drops Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Ocular Sign: Change From Baseline in Total Corneal Staining Score to Day 14
Corneal staining was performed to grade the degree of corneal epithelial cell injury as measured by fluorescence using slit-lamp examination. Ora Calibra® Scale from 0 to 4 with the use of half grade (0.5) increments, where grade 0 = None and 4 = Severe. Total corneal staining score was the sum of all three regions (Inferior, Central and Superior), the score range is from 0 (minimum) to 12 (maximum).
Measured: change from baseline to 2 weeks
Ocular Symptom: Change From Baseline in Patient-Reported Ocular Dryness Score to Day 14, Using Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire
Ocular dryness from the Ora Calibra® Ocular Discomfort \& 4-Symptom Questionnaire was assessed at the subject level in regard to how both eyes felt. The Ora Calibra® Ocular Discomfort \& 4-Symptom Questionnaire was used, which included rating the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging. Each symptom rating ranged from 0 to 5, where 0 = None and 5 = Worst.
Measured: change from baseline to 2 weeks

Secondary outcomes (1)

Eye Dryness: Change From Baseline in Patient-Reported Ocular Symptom to Day 8, Using Visual Analog Scale (VAS)
Visual analog scale (VAS) was measured by asking subjects to rate each ocular symptom due to ocular dryness by placing a vertical mark on a horizontal line of length 100 mm to indicate the level of discomfort where 0 mm = No Discomfort and 100 mm = Maximal Discomfort. Symptoms assessed were burning/stinging, itching, foreign body sensation, blurred vision, eye dryness, photophobia, and pain.
Measured: change from baseline to 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jan 202023 Jun 2020

First posted13 Apr 2020
Study start15 Jan 2020
Primary completion23 Jun 2020
Study completion23 Jun 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Dry Eye SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 220 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04343287
Sponsor's protocol ID: BRM421-18-C001-PR
Status last verified: Sep 2021
First submitted: 9 Apr 2020
Last updated: 1 May 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Dry Eye Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-Center, Randomized, Double Masked, Placebo 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
ClinicalTrials.gov ID: NCT04343287
Acronym / sponsor ID: BRM421-18-C001-PR
Conditions: Dry Eye Syndrome
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 220 participants (actual)
Lead sponsor: BRIM Biotechnology Inc.Industry (pharma, biotech, devices)
Study start: 15 Jan 2020 (actual)
Primary completion: 23 Jun 2020 (actual)
Study completion: 23 Jun 2020 (actual)
First posted: 13 Apr 2020 (actual)
Results: Posted 21 Oct 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed 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).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
BRM421 Ophthalmic Solution	Active comparator	Drug: BRM421A topical solution of BRIM421 ophthalmic drops
Placebo	Placebo comparator	Drug: PlaceboA vehicle ophthalmic drops

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (6 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BRM421The active control with BRM421 solution	Drug	BRM421 Ophthalmic Solution
PlaceboThe vehicle solution	Drug	Placebo

Primary outcome

Ocular Sign: Change From Baseline in Total Corneal Staining Score to Day 14
Time frame: change from baseline to 2 weeks
Corneal staining was performed to grade the degree of corneal epithelial cell injury as measured by fluorescence using slit-lamp examination. Ora Calibra® Scale from 0 to 4 with the use of half grade (0.5) increments, where grade 0 = None and 4 = Severe. Total corneal staining score was the sum of all three regions (Inferior, Central and Superior), the score range is from 0 (minimum) to 12 (maximum).
Ocular Symptom: Change From Baseline in Patient-Reported Ocular Dryness Score to Day 14, Using Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire
Time frame: change from baseline to 2 weeks
Ocular dryness from the Ora Calibra® Ocular Discomfort \& 4-Symptom Questionnaire was assessed at the subject level in regard to how both eyes felt. The Ora Calibra® Ocular Discomfort \& 4-Symptom Questionnaire was used, which included rating the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging. Each symptom rating ranged from 0 to 5, where 0 = None and 5 = Worst.

1 secondary outcome

Eye Dryness: Change From Baseline in Patient-Reported Ocular Symptom to Day 8, Using Visual Analog Scale (VAS)
Time frame: change from baseline to 1 week

Results and safety

Results posted to the registry on 21 Oct 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BRM421 Ophthalmic Solution	108	108
Placebo	112	111

Primary outcome: Ocular Sign: Change From Baseline in Total Corneal Staining Score to Day 14

Time frame: change from baseline to 2 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	BRM421 Ophthalmic Solution n = 81	Placebo n = 83
Value	-1 (1.245)	-0.68 (1.392)

Primary outcome: Ocular Symptom: Change From Baseline in Patient-Reported Ocular Dryness Score to Day 14, Using Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire

Time frame: change from baseline to 2 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	BRM421 Ophthalmic Solution n = 108	Placebo n = 112
Value	-0.3 (0.98)	-0.5 (0.99)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 6 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BRM421 Ophthalmic Solution	1 of 108 (0.9%)	38 of 108 (35.2%)	0 of 108
Placebo	0 of 112 (0%)	46 of 112 (41.1%)	0 of 112

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gail Torkildsen, MD principal investigator

Andover Eye Associates

Blair Boehmer, MD principal investigator

Midwest Cornea Associates, LLC.

David Wirta, MD principal investigator

Eye Research Foundation

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing BRM421 in people with Dry Eye Syndrome, run by BRIM Biotechnology Inc. at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ocular Sign: Change From Baseline in Total Corneal Staining Score to Day 14 (time frame: change from baseline to 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04343287.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.