Trial Outcomes & Findings for Safety and Efficacy of BRM421 for Dry Eye Syndrome Treatment (NCT NCT04343287)

Last Updated: 2021-10-21

Results Overview

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. Regions assessed were the central, superior, inferior, temporal, and nasal. Total corneal staining score was the sum of all five regions. Analyses were for study eye only.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

220 participants

Primary outcome timeframe

2 weeks

Results posted on

2021-10-21

Participant Flow

Participant milestones

Participant milestones
Measure	BRM421 Ophthalmic Solution A topical solution of BRIM421 ophthalmic drops BRM421: The active control with BRM421 solution	Placebo A vehicle ophthalmic drops Placebo: The vehicle solution
Overall Study STARTED	108	112
Overall Study COMPLETED	108	111
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy of BRM421 for Dry Eye Syndrome Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BRM421 Ophthalmic Solution n=108 Participants A topical solution of BRIM421 ophthalmic drops BRM421: The active control with BRM421 solution	Placebo n=112 Participants A vehicle ophthalmic drops Placebo: The vehicle solution	Total n=220 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	50 Participants n=5 Participants	57 Participants n=7 Participants	107 Participants n=5 Participants
Age, Categorical >=65 years	58 Participants n=5 Participants	55 Participants n=7 Participants	113 Participants n=5 Participants
Age, Continuous	63.9 years STANDARD_DEVIATION 10.9 • n=5 Participants	63.4 years STANDARD_DEVIATION 12.07 • n=7 Participants	63.7 years STANDARD_DEVIATION 11.49 • n=5 Participants
Sex: Female, Male Female	69 Participants n=5 Participants	83 Participants n=7 Participants	152 Participants n=5 Participants
Sex: Female, Male Male	39 Participants n=5 Participants	29 Participants n=7 Participants	68 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	100 Participants n=5 Participants	106 Participants n=7 Participants	206 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	9 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	21 Participants n=5 Participants	19 Participants n=7 Participants	40 Participants n=5 Participants
Race (NIH/OMB) White	82 Participants n=5 Participants	84 Participants n=7 Participants	166 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	108 participants n=5 Participants	112 participants n=7 Participants	220 participants n=5 Participants
Total Corneal Fluorescein Staining (0-12: Higher is Worse)	6.19 units on a scale STANDARD_DEVIATION 0.904 • n=5 Participants	6.15 units on a scale STANDARD_DEVIATION 0.835 • n=7 Participants	6.17 units on a scale STANDARD_DEVIATION 0.868 • n=5 Participants
Dryness from Ocular Discomfort & 4-Symptom Questionnaire (0-5: Higher is Worse)	3.0 units on a scale STANDARD_DEVIATION 1.00 • n=5 Participants	3.3 units on a scale STANDARD_DEVIATION 0.93 • n=7 Participants	3.2 units on a scale STANDARD_DEVIATION 0.97 • n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks

Outcome measures

Outcome measures
Measure	BRM421 Ophthalmic Solution n=81 Participants A topical solution of BRIM421 ophthalmic drops BRM421: The active control with BRM421 solution	Placebo n=83 Participants A vehicle ophthalmic drops Placebo: The vehicle solution
Ocular Sign: Change From Baseline in Total Corneal Staining Score to Day 14	-1 score on a scale Standard Deviation 1.245	-0.68 score on a scale Standard Deviation 1.392

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	BRM421 Ophthalmic Solution n=108 Participants A topical solution of BRIM421 ophthalmic drops BRM421: The active control with BRM421 solution	Placebo n=112 Participants A vehicle ophthalmic drops Placebo: The vehicle solution
Ocular Symptom: Change From Baseline in Patient-Reported Ocular Dryness Score to Day 14, Using Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire	-0.3 units on a scale Standard Deviation 0.98	-0.5 units on a scale Standard Deviation 0.99

SECONDARY outcome

Timeframe: 2 weeks

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.

Outcome measures

Outcome measures
Measure	BRM421 Ophthalmic Solution n=108 Participants A topical solution of BRIM421 ophthalmic drops BRM421: The active control with BRM421 solution	Placebo n=112 Participants A vehicle ophthalmic drops Placebo: The vehicle solution
Eye Dryness: Change From Baseline in Patient-Reported Ocular Symptom to Day 14, Using Visual Analog Scale (VAS)	-8.4 score on a scale Standard Deviation 19.22	-3.7 score on a scale Standard Deviation 18.29

Adverse Events

BRM421 Ophthalmic Solution

Serious events: 1 serious events

Other events: 38 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 46 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	BRM421 Ophthalmic Solution n=108 participants at risk A topical solution of BRIM421 ophthalmic drops BRM421: The active control with BRM421 solution	Placebo n=112 participants at risk A vehicle ophthalmic drops Placebo: The vehicle solution
Infections and infestations Osteomyelitis-left second toe/Infections and infestations/Osteomyelitis	0.93% 1/108 • 6 weeks	0.00% 0/112 • 6 weeks

Other adverse events

Other adverse events
Measure	BRM421 Ophthalmic Solution n=108 participants at risk A topical solution of BRIM421 ophthalmic drops BRM421: The active control with BRM421 solution	Placebo n=112 participants at risk A vehicle ophthalmic drops Placebo: The vehicle solution
Eye disorders instillation site pain	35.2% 38/108 • 6 weeks	41.1% 46/112 • 6 weeks

Additional Information

Erin Chang, Vice President of Portfolio Management Department

BRIM Biotechnology, Inc.

Phone: 0226598779

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place