Clinical trial NCT05135286: Safety and Efficacy Study of BRIMOCHOL™ PF and Carbachol PF in Subjects With Emmetropic Phakic and Pseudophakic Presbyopia
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Presbyopia
Lead sponsor: Visus Therapeutics
Sponsor class: OTHER
First posted: 2021-11-26
Enrollment: 450
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Safety and Efficacy Study of BRIMOCHOL™ PF and Carbachol PF in Subjects With Emmetropic Phakic and Pseudophakic Presbyopia

Detailed description: Multicenter, Double-Masked, Randomized, Safety and Efficacy Study of BRIMOCHOL™ PF and Carbachol PF Topical Ophthalmic Solution With Emmetropic Phakic and Pseudophakic Presbyopia

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in near VA
timeFrame: Baseline Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Visus Therapeutics Investigative Site
state: Arizona
city: Phoenix
country: United States
facility: Visus Therapeutics Investigative Site
state: Arizona
city: Sun City
country: United States
facility: Visus Therapeutics Investigative Site
state: Arizona
city: Glendale
country: United States
facility: Visus Therapeutics Investigative Site
state: California
city: Inglewood
country: United States
facility: Visus Therapeutics Investigative Site
state: California
city: Irvine
country: United States
facility: Visus Therapeutics Investigative Site
state: California
city: Mission Hills
country: United States
facility: Visus Therapeutics Investigative Site
state: California
city: Newport Beach
country: United States
facility: Visus Therapeutics Investigative Site
state: California
city: Pasadena
country: United States
facility: Visus Therapeutics Investigative Site
state: California
city: Santa Barbara
country: United States
facility: Visus Therapeutics Investigative Site
state: California
city: Littleton
country: United States
facility: Visus Therapeutics Investigative Site
state: Colorado
city: Danbury
country: United States
facility: Visus Therapeutics Investigative Site
state: Connecticut
city: Crystal River
country: United States
facility: Visus Therapeutics Investigative Site
state: Florida
city: Delray Beach
country: United States
facility: Visus Therapeutics Investigative Site
state: Florida
city: Fort Lauderdale
country: United States
facility: Visus Therapeutics Investigative Site
state: Florida
city: Jacksonville
country: United States
facility: Visus Therapeutics Investigative Site
state: Florida
city: Largo
country: United States
facility: Visus Therapeutics Investigative Site
state: Florida
city: Mount Dora
country: United States
facility: Visus Therapeutics Investigative Site
state: Florida
city: Lake Villa
country: United States
facility: Visus Therapeutics Investigative Site
state: Illinois
city: Indianapolis
country: United States
facility: Visus Therapeutics Investigative Site
state: Indiana
city: Louisville
country: United States
facility: Visus Therapeutics Investigative Site
state: Kentucky
city: Bloomington
country: United States
facility: Visus Therapeutics Investigative Site
state: Minnesota
city: Kansas City
country: United States
facility: Visus Therapeutics Investigative Site
state: Missouri
city: Saint Louis
country: United States
facility: Visus Therapeutics Investigative Site
state: Missouri
city: Henderson
country: United States
facility: Visus Therapeutics Investigative Site
state: Nevada
city: Poughkeepsie
country: United States
facility: Visus Therapeutics Investigative Site
state: New York
city: Garner
country: United States
facility: Visus Therapeutics Investigative Site
state: North Carolina
city: W. Fargo
country: United States
facility: Visus Therapeutics Investigative Site
state: North Dakota
city: Powell
country: United States
facility: Visus Therapeutics Investigative Site
state: Ohio
city: Portland
country: United States
facility: Visus Therapeutics Investigative Site
state: Oregon
city: Cranberry Township
country: United States
facility: Visus Therapeutics Investigative Site
state: Pennsylvania
city: Wilkes-Barre
country: United States
facility: Visus Therapeutics Investigative Site
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Visus Therapeutics Investigative Site
state: South Dakota
city: Maryville
country: United States
facility: Visus Therapeutics Investigative Site
state: Tennessee
city: Memphis
country: United States
facility: Visus Therapeutics Investigative Site
state: Tennessee
city: Smyrna
country: United States
facility: Visus Therapeutics Investigative Site
state: Tennessee
city: Hurst
country: United States
facility: Visus Therapeutics Investigative Site
state: Texas
city: Lakeway
country: United States
facility: Visus Therapeutics Investigative Site
state: Texas
city: San Antonio
country: United States
facility: Visus Therapeutics Investigative Site
state: Texas
city: Draper
country: United States
facility: Visus Therapeutics Investigative Site
state: Utah
city: Falls Church
country: United States
facility: Visus Therapeutics Investigative Site
state: Virginia
city: Lynchburg
country: United States
facility: Visus Therapeutics Investigative Site
state: Virginia
Study officials:
References: