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NCT05270863 Clinical Trial

Safety and Efficacy Study BRIMOCHOL™ PF and Carbachol PF in Subjects With Emmetropic Phakic or Pseudophakic Presbyopia

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05270863
Other study ID # VT-002
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date March 30, 2022
Est. completion date April 10, 2023

Study information
Verified date April 2023
Source Visus Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 182
Est. completion date April 10, 2023
Est. primary completion date March 17, 2023
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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• BRIMOCHOL™ PF
A single drop in each eye at a visit.
• Carbachol PF
A single drop in each eye at a visit.
• Brimonidine tartrate
A single drop in each eye at a visit.

Locations
Country Name City State
United States Visus Therapeutics Investigative Site Cedar Park Texas
United States Visus Therapeutics Investigative Site Glendale California
United States Visus Therapeutics Investigative Site Houston Texas
United States Visus Therapeutics Investigative Site Jacksonville Florida
United States Visus Therapeutics Investigative Site Kansas City Missouri
United States Visus Therapeutics Investigative Site Kansas City Missouri
United States Visus Therapeutics Investigative Site Memphis Tennessee
United States Visus Therapeutics Investigative Site Memphis Tennessee
United States Visus Therapeutics Investigative Site Morrow Georgia
United States Visus Therapeutics Investigative Site Ogden Utah
United States Visus Therapeutics Investigative Site Pittsburgh Pennsylvania
United States Visus Therapeutics Investigative Site Rancho Cordova California
United States Visus Therapeutics Investigative Site Roswell Georgia
United States Visus Therapeutics Investigative Site San Antonio Texas
United States Visus Therapeutics Investigative Site Shawnee Mission Kansas

Sponsors (1)
Lead Sponsor Collaborator
Visus Therapeutics

Country where clinical trial is conducted

United States, 

Outcome
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 Visit 1
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