Trial Outcomes & Findings for Safety and Efficacy of BRM421 for Dry Eye Syndrome (NCT NCT03066219)
NCT ID: NCT03066219
Last Updated: 2026-05-01
Results Overview
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
COMPLETED
PHASE2
157 participants
change from baseline to week 4
2026-05-01
Participant Flow
Participant milestones
| Measure |
BRM421 Ophthalmic Solution
The active control with BRM421 solution
BRM421: A topical solution of BRIM421 ophthalmic drops
|
Placebo
The vehicle solution
Placebo: vehicle ophthalmic drops
|
|---|---|---|
|
Overall Study
STARTED
|
78
|
79
|
|
Overall Study
COMPLETED
|
76
|
75
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of BRM421 for Dry Eye Syndrome
Baseline characteristics by cohort
| Measure |
BRM421 Ophthalmic Solution
n=78 Participants
The active control with BRM421 solution
BRM421: A topical solution of BRIM421 ophthalmic drops
|
Placebo
n=79 Participants
The vehicle solution
Placebo: vehicle ophthalmic drops
|
Total
n=157 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
41 Participants
n=14 Participants
|
41 Participants
n=34 Participants
|
82 Participants
n=69 Participants
|
|
Age, Categorical
>=65 years
|
37 Participants
n=14 Participants
|
38 Participants
n=34 Participants
|
75 Participants
n=69 Participants
|
|
Age, Continuous
|
62.7 years
STANDARD_DEVIATION 12.57 • n=14 Participants
|
63.0 years
STANDARD_DEVIATION 11.78 • n=34 Participants
|
62.9 years
STANDARD_DEVIATION 12.7 • n=69 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=14 Participants
|
59 Participants
n=34 Participants
|
112 Participants
n=69 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=14 Participants
|
20 Participants
n=34 Participants
|
45 Participants
n=69 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=14 Participants
|
4 Participants
n=34 Participants
|
8 Participants
n=69 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
74 Participants
n=14 Participants
|
75 Participants
n=34 Participants
|
149 Participants
n=69 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
1 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=14 Participants
|
1 Participants
n=34 Participants
|
2 Participants
n=69 Participants
|
|
Race (NIH/OMB)
White
|
75 Participants
n=14 Participants
|
78 Participants
n=34 Participants
|
153 Participants
n=69 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
1 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Region of Enrollment
United States
|
78 Participants
n=14 Participants
|
79 Participants
n=34 Participants
|
157 Participants
n=69 Participants
|
|
Ocular Discomfort
|
78 Participants
n=14 Participants
|
79 Participants
n=34 Participants
|
157 Participants
n=69 Participants
|
|
Burning
|
78 Participants
n=14 Participants
|
79 Participants
n=34 Participants
|
157 Participants
n=69 Participants
|
|
Dryness
|
78 Participants
n=14 Participants
|
79 Participants
n=34 Participants
|
157 Participants
n=69 Participants
|
|
Grittiness
|
78 Participants
n=14 Participants
|
79 Participants
n=34 Participants
|
157 Participants
n=69 Participants
|
|
Stinging
|
78 Participants
n=14 Participants
|
79 Participants
n=34 Participants
|
157 Participants
n=69 Participants
|
PRIMARY outcome
Timeframe: change from baseline to week 4The 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
Outcome measures
| Measure |
BRM421 Ophthalmic Solution
n=76 Participants
The active control with BRM421 solution
BRM421: A topical solution of BRIM421 ophthalmic drops
|
Placebo
n=75 Participants
The vehicle solution
Placebo: vehicle ophthalmic drops
|
|---|---|---|
|
Sign: Corneal Fluorescein Staining Score
|
-1.06 score on a scale
Interval -1.5 to -0.62
|
-1.16 score on a scale
Interval -1.61 to -0.71
|
PRIMARY outcome
Timeframe: change from baseline to week 4Ocular 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
Outcome measures
| Measure |
BRM421 Ophthalmic Solution
n=76 Participants
The active control with BRM421 solution
BRM421: A topical solution of BRIM421 ophthalmic drops
|
Placebo
n=75 Participants
The vehicle solution
Placebo: vehicle ophthalmic drops
|
|---|---|---|
|
Symptom: Ocular Discomfort Score
|
0.41 score on a scale
Interval 0.14 to 0.67
|
0.16 score on a scale
Interval -0.14 to 0.46
|
SECONDARY outcome
Timeframe: change from baseline to week 4The 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.
Outcome measures
| Measure |
BRM421 Ophthalmic Solution
n=76 Participants
The active control with BRM421 solution
BRM421: A topical solution of BRIM421 ophthalmic drops
|
Placebo
n=75 Participants
The vehicle solution
Placebo: vehicle ophthalmic drops
|
|---|---|---|
|
Tear Film Break-up Time
|
-0.165 seconds
Interval -0.358 to 0.027
|
0.183 seconds
Interval -0.034 to 0.401
|
SECONDARY outcome
Timeframe: change from baseline to week 4Conjunctival 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
Outcome measures
| Measure |
BRM421 Ophthalmic Solution
n=76 Participants
The active control with BRM421 solution
BRM421: A topical solution of BRIM421 ophthalmic drops
|
Placebo
n=75 Participants
The vehicle solution
Placebo: vehicle ophthalmic drops
|
|---|---|---|
|
Conjunctival Redness
|
-0.14 score on a scale
Interval -0.3 to 0.03
|
-0.1 score on a scale
Interval -0.27 to 0.07
|
SECONDARY outcome
Timeframe: change from baseline to week 4OSDI 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).
Outcome measures
| Measure |
BRM421 Ophthalmic Solution
n=76 Participants
The active control with BRM421 solution
BRM421: A topical solution of BRIM421 ophthalmic drops
|
Placebo
n=75 Participants
The vehicle solution
Placebo: vehicle ophthalmic drops
|
|---|---|---|
|
Ocular Surface Disease Index (OSDI)©
|
-3.89 score on a scale
Interval -6.33 to -1.45
|
-3.04 score on a scale
Interval -5.14 to -0.94
|
Adverse Events
BRM421 Ophthalmic Solution
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BRM421 Ophthalmic Solution
n=78 participants at risk
The active control with BRM421 solution
BRM421: A topical solution of BRIM421 ophthalmic drops
|
Placebo
n=79 participants at risk
The vehicle solution
Placebo: vehicle ophthalmic drops
|
|---|---|---|
|
Eye disorders
instillation site pain
|
5.1%
4/78 • 6 weeks
|
3.8%
3/79 • 6 weeks
|
Additional Information
Alin Ning, Associate Director, Product Development Department
BRIM Biotechnology
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place