Presbyopia Clinical Trial
Official title:
Multicenter, Double-Masked, Randomized, Safety and Efficacy Study of BRIMOCHOL™ PF and Carbachol PF Topical Ophthalmic Solution With Emmetropic Phakic and Pseudophakic Presbyopia
| Verified date | April 2024 |
| Source | Visus Therapeutics |
| Contact | David Le |
| Phone | (800) 281-4536 |
| david.le[@]visustx.com | |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Safety and Efficacy Study of BRIMOCHOL™ PF and Carbachol PF in Subjects With Emmetropic Phakic and Pseudophakic Presbyopia
| Status | Recruiting |
| Enrollment | 450 |
| Est. completion date | December 31, 2024 |
| Est. primary completion date | December 31, 2024 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 45 Years to 80 Years |
| Eligibility | Inclusion Criteria: - Male or female in good general health - Must have presbyopia Exclusion Criteria: - History of allergic reaction to the study drug or any of its components - Any disease or medical condition that, in the opinion of the Investigator, would prevent the subject from participating in the study or might confound study results |
| Country | Name | City | State |
|---|---|---|---|
| United States | Visus Therapeutics Investigative Site | Bloomington | Minnesota |
| United States | Visus Therapeutics Investigative Site | Chandler | Arizona |
| United States | Visus Therapeutics Investigative Site | Cranberry Township | Pennsylvania |
| United States | Visus Therapeutics Investigative Site | Crystal River | Florida |
| United States | Visus Therapeutics Investigative Site | Danbury | Connecticut |
| United States | Visus Therapeutics Investigative Site | Delray Beach | Florida |
| United States | Visus Therapeutics Investigative Site | Draper | Utah |
| United States | Visus Therapeutics Investigative Site | Falls Church | Virginia |
| United States | Visus Therapeutics Investigative Site | Fort Lauderdale | Florida |
| United States | Visus Therapeutics Investigative Site | Garner | North Carolina |
| United States | Visus Therapeutics Investigative Site | Glendale | California |
| United States | Visus Therapeutics Investigative Site | Henderson | Nevada |
| United States | Visus Therapeutics Investigative Site | Hurst | Texas |
| United States | Visus Therapeutics Investigative Site | Indianapolis | Indiana |
| United States | Visus Therapeutics Investigative Site | Inglewood | California |
| United States | Visus Therapeutics Investigative Site | Irvine | California |
| United States | Visus Therapeutics Investigative Site | Jacksonville | Florida |
| United States | Visus Therapeutics Investigative Site | Kansas City | Missouri |
| United States | Visus Therapeutics Investigative Site | Lake Villa | Illinois |
| United States | Visus Therapeutics Investigative Site | Lakeway | Texas |
| United States | Visus Therapeutics Investigative Site | Largo | Florida |
| United States | Visus Therapeutics Investigative Site | Littleton | Colorado |
| United States | Visus Therapeutics Investigative Site | Louisville | Kentucky |
| United States | Visus Therapeutics Investigative Site | Lynchburg | Virginia |
| United States | Visus Therapeutics Investigative Site | Maryville | Tennessee |
| United States | Visus Therapeutics Investigative Site | Memphis | Tennessee |
| United States | Visus Therapeutics Investigative Site | Mission Hills | California |
| United States | Visus Therapeutics Investigative Site | Mount Dora | Florida |
| United States | Visus Therapeutics Investigative Site | Newport Beach | California |
| United States | Visus Therapeutics Investigative Site | Newport Beach | California |
| United States | Visus Therapeutics Investigative Site | Pasadena | California |
| United States | Visus Therapeutics Investigative Site | Phoenix | Arizona |
| United States | Visus Therapeutics Investigative Site | Portland | Oregon |
| United States | Visus Therapeutics Investigative Site | Poughkeepsie | New York |
| United States | Visus Therapeutics Investigative Site | Powell | Ohio |
| United States | Visus Therapeutics Investigative Site | Saint Louis | Missouri |
| United States | Visus Therapeutics Investigative Site | San Antonio | Texas |
| United States | Visus Therapeutics Investigative Site | Santa Barbara | California |
| United States | Visus Therapeutics Investigative Site | Sioux Falls | South Dakota |
| United States | Visus Therapeutics Investigative Site | Smyrna | Tennessee |
| United States | Visus Therapeutics Investigative Site | Sun City | Arizona |
| United States | Visus Therapeutics Investigative Site | W. Fargo | North Dakota |
| United States | Visus Therapeutics Investigative Site | Wilkes-Barre | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Visus Therapeutics |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from baseline in near VA | Percentage of subjects with 3-line improvement in near VA without the loss of at least 1 line in distance VA | Baseline Day 1 |
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