CompletedNCT03066219Updated May 1, 2026Results posted

Safety and Efficacy of BRM421 for Dry Eye Syndrome

A Phase 2 interventional study of BRM421 and Placebo in Dry Eye Syndrome, sponsored by BRIM Biotechnology Inc.. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-01.

Sponsored by BRIM Biotechnology Inc. · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 157
Allocation: Randomized
Ages: 18 Years and older
Sex: All

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.

Read the detailed description

This is a multi-center, double-masked, randomized, vehicle-controlled, phase 2 study in approximately 150 subjects. (75 per treatment arm).

Conditions studied

Dry Eye Syndrome

Browse trials for

Dry Eye Syndromes 1,292

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 157 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.

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 for at least 6 months prior to enrollment;
Have a history of use of 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; acceptable methods of contraception

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 157 participants (actual)

Study arms

Active comparator
BRM421 Ophthalmic Solution
The active control with BRM421 solution
Drug: BRM421
Placebo comparator
Placebo
The vehicle solution
Drug: Placebo

Interventions

DrugBRM421
0.03%(w/v) BRIM421 ophthalmic solution
DrugPlacebo
vehicle ophthalmic drops

What researchers measure

Primary outcomes

Sign: Corneal Fluorescein Staining Score
The staining was graded with the Ora Calibra® Corneal and Conjunctival Staining Scale. The ocular surface was divided into three regions, including superior, central and inferior region. The following scale was used to grade staining of the each region. Half (0.5) grade increments may be used. The total score of corneal fluorescein staining was calculated as the sum of three regions, the score range is 0 (minimum) to 12 (maximum). None 0 = no staining Trace 1 = occasional Mild 2 = countable Moderate 3 = uncountable, but not confluent Severe 4 = confluent
Time frame: change from baseline to week 4
Symptom: Ocular Discomfort Score
Ocular discomfort scores was subjectively graded by the subjects according to the following Ora Calibra® Ocular Discomfort Scale, rating each eye separately, the score range is 0 (minimum) to 4 (maximum). 0 = no discomfort 1. = intermittent awareness 2. = constant awareness 3. = intermittent discomfort 4. = constant discomfort
Time frame: change from baseline to week 4

Secondary outcomes

Tear Film Break-up Time
The examiner was instilled 5 uL of 2% preservative-free sodium fluorescein solution into the inferior conjunctival cul-de-sac of each eye. With the aid of a slit-lamp, the examiner monitored the integrity of the tear film, noting the time (seconds) it takes to form micelles from the time that the eye is opened.
Time frame: change from baseline to week 4
Conjunctival Redness
Conjunctival redness was graded according to the following scale: Half (0.5) unit increments may be used. None 0 = Normal, without vasodilation Trace 1 = Trace ciliary or conjunctival vasodilation Mild 2 = Broad ciliary vasodilation; Moderate 3 = Broad ciliary and slight, horizontal conjunctival vasodilation Severe 4 = Broad ciliary and prominent, horizontal conjunctival vasodilation
Time frame: change from baseline to week 4
Ocular Surface Disease Index (OSDI)©
OSDI scores was subjectively graded by the subjects according to the Ocular Surface and Disease Index (OSDI) Scale. Patients scored each question from 0 to 4 (higher score means more severe), and the OSDI score is the sum of total 12 questions. The score range is 0 (minimum) to 48 (maximum).
Time frame: change from baseline to week 4

Results

Posted May 1, 2026

Participant flow

Participant flow — Overall Study
Milestone	BRM421 Ophthalmic Solution	Placebo
Started	78	79
Completed	76	75
Not completed	2	4

Outcome measures

PrimarySign: Corneal Fluorescein Staining Score

The staining was graded with the Ora Calibra® Corneal and Conjunctival Staining Scale. The ocular surface was divided into three regions, including superior, central and inferior region. The following scale was used to grade staining of the each region. Half (0.5) grade increments may be used. The total score of corneal fluorescein staining was calculated as the sum of three regions, the score range is 0 (minimum) to 12 (maximum). None 0 = no staining Trace 1 = occasional Mild 2 = countable Moderate 3 = uncountable, but not confluent Severe 4 = confluent

Time frame:: change from baseline to week 4
Reported as:: Mean · score on a scale

Sign: Corneal Fluorescein Staining Score
score on a scale	BRM421 Ophthalmic Solution	Placebo
Sign: Corneal Fluorescein Staining Score	-1.06 (-1.5 to -0.62)	-1.16 (-1.61 to -0.71)

PrimarySymptom: Ocular Discomfort Score

Ocular discomfort scores was subjectively graded by the subjects according to the following Ora Calibra® Ocular Discomfort Scale, rating each eye separately, the score range is 0 (minimum) to 4 (maximum). 0 = no discomfort 1. = intermittent awareness 2. = constant awareness 3. = intermittent discomfort 4. = constant discomfort

Time frame:: change from baseline to week 4
Reported as:: Mean · score on a scale

Symptom: Ocular Discomfort Score
score on a scale	BRM421 Ophthalmic Solution	Placebo
Symptom: Ocular Discomfort Score	0.41 (0.14 to 0.67)	0.16 (-0.14 to 0.46)

SecondaryTear Film Break-up Time

The examiner was instilled 5 uL of 2% preservative-free sodium fluorescein solution into the inferior conjunctival cul-de-sac of each eye. With the aid of a slit-lamp, the examiner monitored the integrity of the tear film, noting the time (seconds) it takes to form micelles from the time that the eye is opened.

Time frame:: change from baseline to week 4
Reported as:: Mean · seconds

Tear Film Break-up Time
seconds	BRM421 Ophthalmic Solution	Placebo
Tear Film Break-up Time	-0.165 (-0.358 to 0.027)	0.183 (-0.034 to 0.401)

SecondaryConjunctival Redness

Conjunctival redness was graded according to the following scale: Half (0.5) unit increments may be used. None 0 = Normal, without vasodilation Trace 1 = Trace ciliary or conjunctival vasodilation Mild 2 = Broad ciliary vasodilation; Moderate 3 = Broad ciliary and slight, horizontal conjunctival vasodilation Severe 4 = Broad ciliary and prominent, horizontal conjunctival vasodilation

Time frame:: change from baseline to week 4
Reported as:: Mean · score on a scale

Conjunctival Redness
score on a scale	BRM421 Ophthalmic Solution	Placebo
Conjunctival Redness	-0.14 (-0.3 to 0.03)	-0.1 (-0.27 to 0.07)

SecondaryOcular Surface Disease Index (OSDI)©

OSDI scores was subjectively graded by the subjects according to the Ocular Surface and Disease Index (OSDI) Scale. Patients scored each question from 0 to 4 (higher score means more severe), and the OSDI score is the sum of total 12 questions. The score range is 0 (minimum) to 48 (maximum).

Time frame:: change from baseline to week 4
Reported as:: Mean · score on a scale

Ocular Surface Disease Index (OSDI)©
score on a scale	BRM421 Ophthalmic Solution	Placebo
Ocular Surface Disease Index (OSDI)©	-3.89 (-6.33 to -1.45)	-3.04 (-5.14 to -0.94)

Adverse events

Collected over 6 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
BRM421 Ophthalmic Solution	0/78 (0%)	0/78 (0%)	4/78 (5.1%)
Placebo	0/79 (0%)	0/79 (0%)	3/79 (3.8%)

Most frequent other events

Most frequent other events
Event	BRM421 Ophthalmic Solution	Placebo
instillation site painEye disorders	4/78	3/79

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	BRM421 Ophthalmic Solution	Placebo	Total
<=18 years	0	0	0
Between 18 and 65 years	41	41	82
>=65 years	37	38	75

Age, Continuous
Age, Continuous(years)	BRM421 Ophthalmic Solution	Placebo	Total
Mean	62.7 ± 12.57	63.0 ± 11.78	62.9 ± 12.7

Sex: Female, Male
Sex: Female, Male(Participants)	BRM421 Ophthalmic Solution	Placebo	Total
Female	53	59	112
Male	25	20	45

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	BRM421 Ophthalmic Solution	Placebo	Total
Hispanic or Latino	4	4	8
Not Hispanic or Latino	74	75	149
Unknown or Not Reported	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	BRM421 Ophthalmic Solution	Placebo	Total
American Indian or Alaska Native	0	0	0
Asian	1	0	1
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	1	1	2
White	75	78	153
More than one race	1	0	1
Unknown or Not Reported	0	0	0

Region of Enrollment
Region of Enrollment(Participants)	BRM421 Ophthalmic Solution	Placebo	Total
United States	78	79	157

Ocular Discomfort
Ocular Discomfort(Participants)	BRM421 Ophthalmic Solution	Placebo	Total
Count of participants	78	79	157

Burning
Burning(Participants)	BRM421 Ophthalmic Solution	Placebo	Total
Count of participants	78	79	157

3 further baseline measures are reported on the registry.

Study locations

2 sites

Central Maine Eye Care
Lewiston, Maine 04240, United States
Andover Eye Associates
Andover, Massachusetts 01810, United States

References and documents

Study documents

Protocol and statistical analysis plan · Sep 11, 2019

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03066219
Lead sponsor: BRIM Biotechnology Inc.
Responsible party: Sponsor
First posted: Feb 28, 2017
Start date: Feb 7, 2017
Primary completion: May 20, 2017
Completion: Jun 28, 2017
Results posted: May 1, 2026
Last update: May 1, 2026

Study contacts

Gail Torkildsen, MD

principal investigator · Andover Eye Associates

John Lonsdale, MD

principal investigator · Central Maine Eye Care

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 Oct 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Dry Eye Syndromes→

Other studies from this sponsor

BRIM Biotechnology Inc.

Start the discussion