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Safety and Efficacy Study of BRIMOCHOL™ vs. BRIMOCHOL™ F vs. Carbachol Monotherapy Topical Ophthalmic Solutions in Subjects with Emmetropic Phakic and Pseudophakic Presbyopia
A 3-Dose, Multicenter, Randomized, Double-Masked, Crossover Phase 2 Safety and Efficacy Study of BRIMOCHOL™ Topical Ophthalmic Solution vs. BRIMOCHOL™ F Topical Ophthalmic Solution vs. Monotherapy with Carbachol Topical Ophthalmic Solution in Subjects with Emmetropic Phakic and Pseudophakic Presbyopia
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BRIMOCHOL™ | Experimental | A single drop in each eye at a visit. |
|
| BRIMOCHOL™ F | Experimental | A single drop in each eye at a visit. |
|
| Carbachol | Active Comparator | A single drop in each eye at a visit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BRIMOCHOL™ | Drug | A single drop in each eye at a visit. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects With a >=15 Letter Gain Without a < 5 Letter Loss in Near Visual Acuity | Primary Endpoint measured at Hour 1 post-dose at Study Visit - a Single drop Cohort | Day 1, Hour 1 post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline ETDRS Letters Score in Distance Visual Acuity | Secondary Endpoint measured at Hour 1 post-dose at Study Visit - a Single drop Cohort | Day 1, Hour 1 post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Global Research Management, Inc. | Glendale | California | 91204 | United States | ||
| Eye Research Foundation |
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| ID | Title | Description |
|---|---|---|
| FG000 | B, C, BF | Crossover design with 3 study treatments. Participants received Brimonidine, Carbachol PF, or BRIMOCHOL PF. |
| FG001 | B, BF, C | Crossover design with 3 study treatments. Participants received Brimonidine, BRIMOCHOL PF, or Carbachol PF. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Visit 2 First Intervention |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 29, 2021 | Nov 25, 2024 |
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| BRIMOCHOL™ F | Drug | A single drop in each eye at a visit. |
|
|
| Carbachol | Drug | A single drop in each eye at a visit. |
|
|
| Newport Beach |
| California |
| 92663 |
| United States |
| Total Eye Care, PA | Memphis | Tennessee | 38119 | United States |
| FG002 | C, B, BF | Crossover design with 3 study treatments. Participants received Carbachol PF, Brimonidine, or BRIMOCHOL PF. |
| FG003 | C, BF, B | Crossover design with 3 study treatments. Participants received Carbachol PF, BRIMOCHOL PF, or Brimonidine |
| FG004 | BF, B, C | Crossover design with 3 study treatments. Participants received BRIMOCHOL PF, Brimonidine, or Carbachol PF. |
| FG005 | BF, C, B | Crossover design with 3 study treatments. Participants received BRIMOCHOL PF, Carbachol PF, or Brimonidine. |
| COMPLETED |
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| NOT COMPLETED |
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| First Washout |
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| Visit 3 Second Intervention |
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| Second Washout |
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| Visit 4 Third Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Drop Cohort | A single drop in each eye at a visit. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 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 | Proportion of Subjects With a >=15 Letter Gain Without a < 5 Letter Loss in Near Visual Acuity | Primary Endpoint measured at Hour 1 post-dose at Study Visit - a Single drop Cohort | Posted | Count of Participants | Participants | Day 1, Hour 1 post-dose |
|
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline ETDRS Letters Score in Distance Visual Acuity | Secondary Endpoint measured at Hour 1 post-dose at Study Visit - a Single drop Cohort | Posted | Mean | Standard Deviation | ETDRS letters | Day 1, Hour 1 post-dose |
|
|
30 days
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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 | BRIMOCHOL | Single drop cohort | 0 | 17 | 0 | 17 | 1 | 17 |
| EG001 | BRIMOCHOL PF | Single drop cohort | 0 | 18 | 0 | 18 | 1 | 18 |
| EG002 | Carbachol PF | Single drop cohort | 0 | 17 | 0 | 17 | 0 | 17 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye irritation | Eye disorders | Systematic Assessment |
| ||
| Eye pain | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Visus Therapeutics | Visus Therapeutics, Inc. | 800-281-4536 | trials.info@visustx.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 1, 2021 | Nov 25, 2024 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D002217 | Carbachol |
| D000068438 | Brimonidine Tartrate |
| ID | Term |
|---|---|
| D002794 | Choline |
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009861 | Onium Compounds |
| D011810 | Quinoxalines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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