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

April 17, 2023 updated by: Visus Therapeutics

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Change from baseline in near VA
Time Frame: Baseline Visit 1
Percentage of subjects with 3-line improvement in near VA without the loss of at least 1 line in distance VA
Baseline Visit 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Visus Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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)

April 20, 2023

Last Update Submitted That Met QC Criteria

April 17, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Presbyopia

Clinical Trials on BRIMOCHOL™ PF

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bulgaria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe