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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, placebo-controlled, phase 2/3 study with approximately 200 subjects. (around 100 subjects per treatment arm).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BRM421 Ophthalmic Solution | Active Comparator | A topical solution of BRIM421 ophthalmic drops |
|
| Placebo | Placebo Comparator | A vehicle ophthalmic drops |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BRM421 | Drug | The active control with BRM421 solution |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | change from baseline to 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gail Torkildsen, MD | Andover Eye Associates | Principal Investigator |
| Blair Boehmer, MD | Midwest Cornea Associates, LLC. | Principal Investigator |
| David Wirta, MD | Eye Research Foundation | Principal Investigator |
| Eugene B McLaurin, MD | Total Eye Care, PA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye Research Foundation | Newport Beach | California | 92663 | United States | ||
| Midwest Cornea Associates, LLC |
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| ID | Title | Description |
|---|---|---|
| FG000 | BRM421 Ophthalmic Solution | A topical solution of BRIM421 ophthalmic drops BRM421: The active control with BRM421 solution |
| FG001 | Placebo | A vehicle ophthalmic drops Placebo: The vehicle solution |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Intent-to-treat (ITT) set included all randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | BRM421 Ophthalmic Solution | A topical solution of BRIM421 ophthalmic drops BRM421: The active control with BRM421 solution |
| BG001 | Placebo | A vehicle ophthalmic drops Placebo: The vehicle solution |
| 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 | 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). | Posted | Mean | Standard Deviation | score on a scale | change from baseline to 2 weeks |
|
6 weeks
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| 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 | A topical solution of BRIM421 ophthalmic drops BRM421: The active control with BRM421 solution |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Osteomyelitis | Infections and infestations | Systematic Assessment | Non-ocular SAE |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| instillation site pain | Eye disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alin Ning, Associate Director, Product Development Department | BRIM Biotechnology, Inc. | +886-2659-8586 | alin.ning@brimbiotech.com |
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| 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 | Dec 10, 2019 | Dec 21, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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Double Masking
| Placebo |
| Drug |
The vehicle solution |
|
| change from baseline to 1 week |
| Indianapolis |
| Indiana |
| 46290 |
| United States |
| Andover Eye Associates | Andover | Massachusetts | 01810 | United States |
| Total Eye Care | Memphis | Tennessee | 38119 | United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Total Corneal Fluorescein Staining | Total Corneal Fluorescein Staining (0-12: Higher is Worse) | Mean | Standard Deviation | units on a scale |
|
| Dryness from Ocular Discomfort & 4-Symptom Questionnaire | Dryness from Ocular Discomfort & 4-Symptom Questionnaire (0-5: Higher is Worse) | Mean | Standard Deviation | units on a scale |
|
A vehicle ophthalmic drops
Placebo: The vehicle solution
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | change from baseline to 2 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | change from baseline to 1 week |
|
|
|
| 0 |
| 108 |
| 1 |
| 108 |
| 38 |
| 108 |
| EG001 | Placebo | A vehicle ophthalmic drops Placebo: The vehicle solution | 0 | 112 | 0 | 112 | 46 | 112 |
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