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

April 22, 2024 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

Recruiting

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 (Estimated)

450

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
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Recruiting
        • Visus Therapeutics Investigative Site
        • Contact:
          • M. Farooqi
          • Phone Number: 480-999-5458
      • Phoenix, Arizona, United States, 85032
        • Recruiting
        • Visus Therapeutics Investigative Site
        • Contact:
          • A. Buschman
          • Phone Number: 480-999-5458
      • Sun City, Arizona, United States, 85351
        • Recruiting
        • Visus Therapeutics Investigative Site
        • Contact:
          • A. Buschman
          • Phone Number: 480-999-5458
    • California
      • Glendale, California, United States, 91204
        • Recruiting
        • Visus Therapeutics Investigative Site
        • Contact:
          • O. Karram
          • Phone Number: 818-246-2560
      • Inglewood, California, United States, 90301
        • Recruiting
        • Visus Therapeutics Investigative Site
        • Contact:
          • C. Caballero-Marin
          • Phone Number: 310-641-4673
      • Irvine, California, United States, 92604
        • Recruiting
        • Visus Therapeutics Investigative Site
        • Contact:
          • L. Zavalza
          • Phone Number: 949-733-2022
      • Mission Hills, California, United States, 91345
        • Recruiting
        • Visus Therapeutics Investigative Site
        • Contact:
          • K. Taylor
          • Phone Number: 661-609-2475
      • Newport Beach, California, United States, 92663
        • Recruiting
        • Visus Therapeutics Investigative Site
        • Contact:
          • R. Castillo
          • Phone Number: 949-427-6099
      • Newport Beach, California, United States, 92663
        • Active, not recruiting
        • Visus Therapeutics Investigative Site
      • Pasadena, California, United States, 91107
        • Recruiting
        • Visus Therapeutics Investigative Site
        • Contact:
          • S. Wade
          • Phone Number: 626-793-4168
      • Santa Barbara, California, United States, 93105
        • Recruiting
        • Visus Therapeutics Investigative Site
        • Contact:
          • K. Rosenbusch
          • Phone Number: 480-999-5458
    • Colorado
      • Littleton, Colorado, United States, 80120
        • Recruiting
        • Visus Therapeutics Investigative Site
        • Contact:
          • Sh. Patel
          • Phone Number: 720-709-7533
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Recruiting
        • Visus Therapeutics Investigative Site
        • Contact:
          • A. Smit
          • Phone Number: 203-791-2020
    • Florida
      • Crystal River, Florida, United States, 34429
        • Recruiting
        • Visus Therapeutics Investigative Site
        • Contact:
          • N. Smith
          • Phone Number: 352-563-1865
      • Delray Beach, Florida, United States, 33484
        • Recruiting
        • Visus Therapeutics Investigative Site
        • Contact:
          • Y. King
          • Phone Number: 561-315-5219
      • Fort Lauderdale, Florida, United States, 33309
        • Recruiting
        • Visus Therapeutics Investigative Site
        • Contact:
          • V. Jean-Baptiste
          • Phone Number: 954-597-6445
      • Jacksonville, Florida, United States, 32256
        • Recruiting
        • Visus Therapeutics Investigative Site
        • Contact:
          • J. Montgomery
          • Phone Number: 904-296-0098
      • Largo, Florida, United States, 33770
        • Recruiting
        • Visus Therapeutics Investigative Site
        • Contact:
          • R. Bondurant
          • Phone Number: 727-450-4668
      • Mount Dora, Florida, United States, 32757
        • Recruiting
        • Visus Therapeutics Investigative Site
        • Contact:
          • N. Woodall
          • Phone Number: 352-989-0932
    • Illinois
      • Lake Villa, Illinois, United States, 60046
        • Recruiting
        • Visus Therapeutics Investigative Site
        • Contact:
          • A. Wojtysiak
          • Phone Number: 847-445-5491
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Recruiting
        • Visus Therapeutics Investigative Site
        • Contact:
          • M. Price
          • Phone Number: 317-844-5530
    • Kentucky
      • Louisville, Kentucky, United States, 40206
        • Recruiting
        • Visus Therapeutics Investigative Site
        • Contact:
          • J. Powell-Sutton
          • Phone Number: 502-589-1500
    • Minnesota
      • Bloomington, Minnesota, United States, 55420
        • Recruiting
        • Visus Therapeutics Investigative Site
        • Contact:
          • N. Jacobs
          • Phone Number: 612-770-6808
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Recruiting
        • Visus Therapeutics Investigative Site
        • Contact:
          • M. Hefter
          • Phone Number: 816-531-9100
      • Saint Louis, Missouri, United States, 63128
        • Recruiting
        • Visus Therapeutics Investigative Site
        • Contact:
          • K. Tincknell
          • Phone Number: 314-842-2020
    • Nevada
      • Henderson, Nevada, United States, 89502
        • Recruiting
        • Visus Therapeutics Investigative Site
        • Contact:
          • P. Bouddhabandith
          • Phone Number: 480-999-5458
    • New York
      • Poughkeepsie, New York, United States, 12603
        • Recruiting
        • Visus Therapeutics Investigative Site
        • Contact:
          • C. Sportiello
          • Phone Number: 845-454-1025
    • North Carolina
      • Garner, North Carolina, United States, 27529
        • Recruiting
        • Visus Therapeutics Investigative Site
        • Contact:
          • J. Newsome
          • Phone Number: 252-904-5415
    • North Dakota
      • W. Fargo, North Dakota, United States, 58078
        • Recruiting
        • Visus Therapeutics Investigative Site
        • Contact:
          • A. Saville
          • Phone Number: 701-809-9905
    • Ohio
      • Powell, Ohio, United States, 43065
        • Recruiting
        • Visus Therapeutics Investigative Site
        • Contact:
          • J. Smith
          • Phone Number: 614-793-0700
    • Oregon
      • Portland, Oregon, United States, 97210
        • Recruiting
        • Visus Therapeutics Investigative Site
        • Contact:
          • J. Rees
          • Phone Number: 503-413-8202
    • Pennsylvania
      • Cranberry Township, Pennsylvania, United States, 16066
        • Recruiting
        • Visus Therapeutics Investigative Site
        • Contact:
          • N. Hindman
          • Phone Number: 724-772-3000
      • Wilkes-Barre, Pennsylvania, United States, 18702
        • Recruiting
        • Visus Therapeutics Investigative Site
        • Contact:
          • B. Michalek
          • Phone Number: 570-270-5281
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57108
        • Recruiting
        • Visus Therapeutics Investigative Site
        • Contact:
          • K. Dunne
          • Phone Number: 605-361-3937
    • Tennessee
      • Maryville, Tennessee, United States, 37803
        • Recruiting
        • Visus Therapeutics Investigative Site
        • Contact:
          • K. Rivera
          • Phone Number: 865-671-1234
      • Memphis, Tennessee, United States, 38119
        • Recruiting
        • Visus Therapeutics Investigative Site
        • Contact:
          • D. Ashe
          • Phone Number: 901-761-4620
      • Smyrna, Tennessee, United States, 37167
        • Recruiting
        • Visus Therapeutics Investigative Site
        • Contact:
          • M. Medlin
          • Phone Number: 615-502-2871
    • Texas
      • Hurst, Texas, United States, 76054
        • Recruiting
        • Visus Therapeutics Investigative Site
        • Contact:
          • B. Bott
          • Phone Number: 817-540-6060
      • Lakeway, Texas, United States, 78738
        • Recruiting
        • Visus Therapeutics Investigative Site
        • Contact:
          • S. Boldt
          • Phone Number: 512-721-8352
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Visus Therapeutics Investigative Site
        • Contact:
          • C. Hazen
          • Phone Number: 210-424-2584
    • Utah
      • Draper, Utah, United States, 84020
        • Recruiting
        • Visus Therapeutics Investigative Site
        • Contact:
          • M. Avila, MD
          • Phone Number: 801-988-7346
    • Virginia
      • Falls Church, Virginia, United States, 22046
        • Recruiting
        • Visus Therapeutics Investigative Site
        • Contact:
          • K. Ng
          • Phone Number: 202-239-0777
      • Lynchburg, Virginia, United States, 24502
        • Recruiting
        • Visus Therapeutics Investigative Site
        • Contact:
          • C. Torrence
          • Phone Number: 434-947-3984

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: Parallel 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
Placebo Comparator: Vehicle
A single drop in each eye at a visit.
Drug: Vehicle
A single drop in each eye at a visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in near VA
Time Frame: Baseline Day 1
Percentage of subjects with 3-line improvement in near VA without the loss of at least 1 line in distance VA
Baseline Day 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 15, 2022

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

November 4, 2021

First Submitted That Met QC Criteria

November 19, 2021

First Posted (Actual)

November 26, 2021

Study Record Updates

Last Update Posted (Actual)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 22, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VT-003

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.

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