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

Visus Therapeutics182 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

182

Conditions

Presbyopia

Interventions

BRIMOCHOL™ PFDRUG

A single drop in each eye at a visit.

Carbachol PFDRUG

A single drop in each eye at a visit.

Brimonidine tartrateDRUG

A single drop in each eye at a visit.

Eligibility

Sex: ALLMin age: 45 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (15)

Visus Therapeutics Investigative Site

Glendale, California, United States

Visus Therapeutics Investigative Site

Rancho Cordova, California, United States

Outcomes

Primary Outcomes

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

Time frame: Day 1 Hour 1

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.