Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
This is a multi-center, double-masked, randomized, vehicle-controlled, phase 2 study in approximately 150 subjects. (75 per treatment arm).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BRM421 Ophthalmic Solution | Active Comparator | The active control with BRM421 solution |
|
| Placebo | Placebo Comparator | The vehicle solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BRM421 | Drug | 0.03%(w/v) BRIM421 ophthalmic solution |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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
| change from baseline to week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | change from baseline to week 4 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gail Torkildsen, MD | Andover Eye Associates | Principal Investigator |
| John Lonsdale, MD | Central Maine Eye Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Maine Eye Care | Lewiston | Maine | 04240 | United States | ||
| Andover Eye Associates |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | BRM421 Ophthalmic Solution | The active control with BRM421 solution BRM421: A topical solution of BRIM421 ophthalmic drops |
| FG001 | Placebo | The vehicle solution Placebo: vehicle ophthalmic drops |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | BRM421 Ophthalmic Solution | The active control with BRM421 solution BRM421: A topical solution of BRIM421 ophthalmic drops |
| BG001 | Placebo | The vehicle solution Placebo: vehicle ophthalmic drops |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | 95% Confidence Interval | score on a scale | change from baseline to week 4 |
|
6 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BRM421 Ophthalmic Solution | The active control with BRM421 solution BRM421: A topical solution of BRIM421 ophthalmic drops |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| instillation site pain | Eye disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alin Ning, Associate Director, Product Development Department | BRIM Biotechnology | +886 226598586 | alin.ning@brimbiotech.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 11, 2019 | Apr 13, 2026 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
vehicle ophthalmic drops |
|
| 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 | 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). | change from baseline to week 4 |
| Andover |
| Massachusetts |
| 01810 |
| United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Ocular Discomfort | Count of Participants | Participants |
|
| Burning | Count of Participants | Participants |
|
| Dryness | Count of Participants | Participants |
|
| Grittiness | Count of Participants | Participants |
|
| Stinging | Count of Participants | Participants |
|
| Placebo |
The vehicle solution Placebo: vehicle ophthalmic drops |
|
|
| Primary | 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
| Posted | Mean | 95% Confidence Interval | score on a scale | change from baseline to week 4 |
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | seconds | change from baseline to week 4 |
|
|
|
| Secondary | 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 | Posted | Mean | 95% Confidence Interval | score on a scale | change from baseline to week 4 |
|
|
|
| Secondary | 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). | Posted | Mean | 95% Confidence Interval | score on a scale | change from baseline to week 4 |
|
|
|
| 0 |
| 78 |
| 0 |
| 78 |
| 4 |
| 78 |
| EG001 | Placebo | The vehicle solution Placebo: vehicle ophthalmic drops | 0 | 79 | 0 | 79 | 3 | 79 |
Not provided
Not provided