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

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

Study Overview

• Status: Completed
• Conditions: Presbyopia
• Intervention / Treatment: Drug: BRIMOCHOL™ PF; Drug: Carbachol PF; Drug: Brimonidine tartrate

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

• Study Type: Interventional
• Enrollment (Actual): 182
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Glendale, California, United States, 91204
      • Visus Therapeutics Investigative Site
    • Rancho Cordova, California, United States, 95670
      • Visus Therapeutics Investigative Site
  • Florida
    • Jacksonville, Florida, United States, 32204
      • Visus Therapeutics Investigative Site
  • Georgia
    • Morrow, Georgia, United States, 30260
      • Visus Therapeutics Investigative Site
    • Roswell, Georgia, United States, 30076
      • Visus Therapeutics Investigative Site
  • Kansas
    • Shawnee Mission, Kansas, United States, 66204
      • Visus Therapeutics Investigative Site
  • Missouri
    • Kansas City, Missouri, United States, 64133
      • Visus Therapeutics Investigative Site
    • Kansas City, Missouri, United States, 64154
      • Visus Therapeutics Investigative Site
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 66762
      • Visus Therapeutics Investigative Site
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Visus Therapeutics Investigative Site
    • Memphis, Tennessee, United States, 77027
      • Visus Therapeutics Investigative Site
  • Texas
    • Cedar Park, Texas, United States, 78613
      • Visus Therapeutics Investigative Site
    • Houston, Texas, United States, 77027
      • Visus Therapeutics Investigative Site
    • San Antonio, Texas, United States, 78229
      • Visus Therapeutics Investigative Site
  • Utah
    • Ogden, Utah, United States, 84403
      • Visus Therapeutics Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BRIMOCHOL™ PF; A single drop in each eye at a visit.	Drug: BRIMOCHOL™ PF; A single drop in each eye at a visit.; Other Names: carbachol/brimonidine tartrate
Active Comparator: Carbachol PF; A single drop in each eye at a visit.	Drug: Carbachol PF; A single drop in each eye at a visit.; Other Names: carbachol monotherapy
Active Comparator: Brimonidine tartrate; A single drop in each eye at a visit.	Drug: Brimonidine tartrate; A single drop in each eye at a visit.; Other Names: brimonidine tartrate monotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day 1 Hour 1

Collaborators and Investigators

• Sponsor: Visus Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2022
• Primary Completion (Actual): March 17, 2023
• Study Completion (Actual): April 10, 2023

Study Registration Dates

• First Submitted: February 25, 2022
• First Submitted That Met QC Criteria: February 25, 2022
• First Posted (Actual): March 8, 2022

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 1, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Protective Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Cardiotonic Agents; Cholinergic Agonists; Miotics; Brimonidine Tartrate; Carbachol
• Other Study ID Numbers: VT-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No