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Safety and Efficacy Study of BRIMOCHOL™ PF and Carbachol PF in Subjects With Emmetropic Phakic and Pseudophakic Presbyopia
Multicenter, Double-Masked, Randomized, Safety and Efficacy Study of BRIMOCHOL™ PF and Carbachol PF Topical Ophthalmic Solution With Emmetropic Phakic and Pseudophakic Presbyopia
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BRIMOCHOL™ PF | Experimental | A single drop in each eye at a visit. |
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| Carbachol PF | Active Comparator | A single drop in each eye at a visit. |
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| Brimonidine tartrate | Active Comparator | A single drop in each eye at a visit. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BRIMOCHOL™ PF | Drug | A single drop in each eye at a visit. |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects With >=15 Letter Gain Without >=5 Letter Loss in Near Visual Acuity | Primary endpoint measure at hour 1 post-dose at study visit | Day 1 Hour 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Visus Therapeutics Investigative Site | Glendale | California | 91204 | United States | ||
| Visus Therapeutics Investigative Site |
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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 | Apr 4, 2023 | Jul 9, 2024 |
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| Carbachol PF | Drug | A single drop in each eye at a visit. |
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| Brimonidine tartrate | Drug | A single drop in each eye at a visit. |
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| Rancho Cordova |
| California |
| 95670 |
| United States |
| Visus Therapeutics Investigative Site | Jacksonville | Florida | 32204 | United States |
| Visus Therapeutics Investigative Site | Morrow | Georgia | 30260 | United States |
| Visus Therapeutics Investigative Site | Roswell | Georgia | 30076 | United States |
| Visus Therapeutics Investigative Site | Shawnee Mission | Kansas | 66204 | United States |
| Visus Therapeutics Investigative Site | Kansas City | Missouri | 64133 | United States |
| Visus Therapeutics Investigative Site | Kansas City | Missouri | 64154 | United States |
| Visus Therapeutics Investigative Site | Pittsburgh | Pennsylvania | 66762 | United States |
| Visus Therapeutics Investigative Site | Memphis | Tennessee | 38119 | United States |
| Visus Therapeutics Investigative Site | Memphis | Tennessee | 77027 | United States |
| Visus Therapeutics Investigative Site | Cedar Park | Texas | 78613 | United States |
| Visus Therapeutics Investigative Site | Houston | Texas | 77027 | United States |
| Visus Therapeutics Investigative Site | San Antonio | Texas | 78229 | United States |
| Visus Therapeutics Investigative Site | Ogden | Utah | 84403 | 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 Invervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | 3 study treatments across 4 study visits |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| 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 >=15 Letter Gain Without >=5 Letter Loss in Near Visual Acuity | Primary endpoint measure at hour 1 post-dose at study visit | All participants who received at least one dose of study treatment (mITT) | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 1 Hour 1 |
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45 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™ PF | A single drop in each eye at a visit. BRIMOCHOL™ PF: A single drop in each eye at a visit. | 0 | 178 | 1 | 178 | 37 | 178 |
| EG001 | Carbachol PF | A single drop in each eye at a visit. Carbachol PF: A single drop in each eye at a visit. | 0 | 177 | 0 | 177 | 24 | 177 |
| EG002 | Brimonidine Tartrate | A single drop in each eye at a visit. Brimonidine tartrate: A single drop in each eye at a visit. | 0 | 176 | 0 | 176 | 2 | 176 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nephrolithiasis | Renal and urinary disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye Irritation | Eye disorders | Systematic Assessment |
| ||
| Headache | Nervous system 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 | Apr 4, 2023 | Jul 9, 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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| Lost to Follow-up |
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| Lost to Follow-up |
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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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