Clinical trial NCT05270863: Safety and Efficacy Study BRIMOCHOL™ PF and Carbachol PF in Subjects With Emmetropic Phakic or 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: COMPLETED
Phase: PHASE3
Conditions: Presbyopia
Lead sponsor: Visus Therapeutics
Sponsor class: OTHER
First posted: 2022-03-08
Enrollment: 182
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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: Proportion of Subjects With >=15 Letter Gain Without >=5 Letter Loss in Near Visual Acuity
timeFrame: Day 1 Hour 1
Secondary outcomes:
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Visus Therapeutics Investigative Site
state: California
city: Rancho Cordova
country: United States
facility: Visus Therapeutics Investigative Site
state: California
city: Jacksonville
country: United States
facility: Visus Therapeutics Investigative Site
state: Florida
city: Morrow
country: United States
facility: Visus Therapeutics Investigative Site
state: Georgia
city: Roswell
country: United States
facility: Visus Therapeutics Investigative Site
state: Georgia
city: Shawnee Mission
country: United States
facility: Visus Therapeutics Investigative Site
state: Kansas
city: Kansas City
country: United States
facility: Visus Therapeutics Investigative Site
state: Missouri
city: Kansas City
country: United States
facility: Visus Therapeutics Investigative Site
state: Missouri
city: Pittsburgh
country: United States
facility: Visus Therapeutics Investigative Site
state: Pennsylvania
city: Memphis
country: United States
facility: Visus Therapeutics Investigative Site
state: Tennessee
city: Memphis
country: United States
facility: Visus Therapeutics Investigative Site
state: Tennessee
city: Cedar Park
country: United States
facility: Visus Therapeutics Investigative Site
state: Texas
city: Houston
country: United States
facility: Visus Therapeutics Investigative Site
state: Texas
city: San Antonio
country: United States
facility: Visus Therapeutics Investigative Site
state: Texas
city: Ogden
country: United States
facility: Visus Therapeutics Investigative Site
state: Utah
Study officials:
References: