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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05135286
Recruitment Status : Recruiting
First Posted : November 26, 2021
Last Update Posted : April 23, 2024
Sponsor:
Information provided by (Responsible Party):
Visus Therapeutics

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

Condition or disease Intervention/treatment Phase
Presbyopia Drug: BRIMOCHOL™ PF Drug: Carbachol PF Drug: Vehicle Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : March 15, 2022
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Carbachol

Arms and Interventions
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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 Name: 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 Name: 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05135286


Contacts
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Contact: David Le (800) 281-4536 david.le@visustx.com

Locations
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United States, Arizona
Visus Therapeutics Investigative Site Recruiting
Chandler, Arizona, United States, 85224
Contact: M. Farooqi    480-999-5458      
Visus Therapeutics Investigative Site Recruiting
Phoenix, Arizona, United States, 85032
Contact: A. Buschman    480-999-5458      
Visus Therapeutics Investigative Site Recruiting
Sun City, Arizona, United States, 85351
Contact: A. Buschman    480-999-5458      
United States, California
Visus Therapeutics Investigative Site Recruiting
Glendale, California, United States, 91204
Contact: O. Karram    818-246-2560      
Visus Therapeutics Investigative Site Recruiting
Inglewood, California, United States, 90301
Contact: C. Caballero-Marin    310-641-4673      
Visus Therapeutics Investigative Site Recruiting
Irvine, California, United States, 92604
Contact: L. Zavalza    949-733-2022      
Visus Therapeutics Investigative Site Recruiting
Mission Hills, California, United States, 91345
Contact: K. Taylor    661-609-2475      
Visus Therapeutics Investigative Site Recruiting
Newport Beach, California, United States, 92663
Contact: R. Castillo    949-427-6099      
Visus Therapeutics Investigative Site Active, not recruiting
Newport Beach, California, United States, 92663
Visus Therapeutics Investigative Site Recruiting
Pasadena, California, United States, 91107
Contact: S. Wade    626-793-4168      
Visus Therapeutics Investigative Site Recruiting
Santa Barbara, California, United States, 93105
Contact: K. Rosenbusch    480-999-5458      
United States, Colorado
Visus Therapeutics Investigative Site Recruiting
Littleton, Colorado, United States, 80120
Contact: Sh. Patel    720-709-7533      
United States, Connecticut
Visus Therapeutics Investigative Site Recruiting
Danbury, Connecticut, United States, 06810
Contact: A. Smit    203-791-2020      
United States, Florida
Visus Therapeutics Investigative Site Recruiting
Crystal River, Florida, United States, 34429
Contact: N. Smith    352-563-1865      
Visus Therapeutics Investigative Site Recruiting
Delray Beach, Florida, United States, 33484
Contact: Y. King    561-315-5219      
Visus Therapeutics Investigative Site Recruiting
Fort Lauderdale, Florida, United States, 33309
Contact: V. Jean-Baptiste    954-597-6445      
Visus Therapeutics Investigative Site Recruiting
Jacksonville, Florida, United States, 32256
Contact: J. Montgomery    904-296-0098      
Visus Therapeutics Investigative Site Recruiting
Largo, Florida, United States, 33770
Contact: R. Bondurant    727-450-4668      
Visus Therapeutics Investigative Site Recruiting
Mount Dora, Florida, United States, 32757
Contact: N. Woodall    352-989-0932      
United States, Illinois
Visus Therapeutics Investigative Site Recruiting
Lake Villa, Illinois, United States, 60046
Contact: A. Wojtysiak    847-445-5491      
United States, Indiana
Visus Therapeutics Investigative Site Recruiting
Indianapolis, Indiana, United States, 46260
Contact: M. Price    317-844-5530      
United States, Kentucky
Visus Therapeutics Investigative Site Recruiting
Louisville, Kentucky, United States, 40206
Contact: J. Powell-Sutton    502-589-1500      
United States, Minnesota
Visus Therapeutics Investigative Site Recruiting
Bloomington, Minnesota, United States, 55420
Contact: N. Jacobs    612-770-6808      
United States, Missouri
Visus Therapeutics Investigative Site Recruiting
Kansas City, Missouri, United States, 64111
Contact: M. Hefter    816-531-9100      
Visus Therapeutics Investigative Site Recruiting
Saint Louis, Missouri, United States, 63128
Contact: K. Tincknell    314-842-2020      
United States, Nevada
Visus Therapeutics Investigative Site Recruiting
Henderson, Nevada, United States, 89502
Contact: P. Bouddhabandith    480-999-5458      
United States, New York
Visus Therapeutics Investigative Site Recruiting
Poughkeepsie, New York, United States, 12603
Contact: C. Sportiello    845-454-1025      
United States, North Carolina
Visus Therapeutics Investigative Site Recruiting
Garner, North Carolina, United States, 27529
Contact: J. Newsome    252-904-5415      
United States, North Dakota
Visus Therapeutics Investigative Site Recruiting
W. Fargo, North Dakota, United States, 58078
Contact: A. Saville    701-809-9905      
United States, Ohio
Visus Therapeutics Investigative Site Recruiting
Powell, Ohio, United States, 43065
Contact: J. Smith    614-793-0700      
United States, Oregon
Visus Therapeutics Investigative Site Recruiting
Portland, Oregon, United States, 97210
Contact: J. Rees    503-413-8202      
United States, Pennsylvania
Visus Therapeutics Investigative Site Recruiting
Cranberry Township, Pennsylvania, United States, 16066
Contact: N. Hindman    724-772-3000      
Visus Therapeutics Investigative Site Recruiting
Wilkes-Barre, Pennsylvania, United States, 18702
Contact: B. Michalek    570-270-5281      
United States, South Dakota
Visus Therapeutics Investigative Site Recruiting
Sioux Falls, South Dakota, United States, 57108
Contact: K. Dunne    605-361-3937      
United States, Tennessee
Visus Therapeutics Investigative Site Recruiting
Maryville, Tennessee, United States, 37803
Contact: K. Rivera    865-671-1234      
Visus Therapeutics Investigative Site Recruiting
Memphis, Tennessee, United States, 38119
Contact: D. Ashe    901-761-4620      
Visus Therapeutics Investigative Site Recruiting
Smyrna, Tennessee, United States, 37167
Contact: M. Medlin    615-502-2871      
United States, Texas
Visus Therapeutics Investigative Site Recruiting
Hurst, Texas, United States, 76054
Contact: B. Bott    817-540-6060      
Visus Therapeutics Investigative Site Recruiting
Lakeway, Texas, United States, 78738
Contact: S. Boldt    512-721-8352      
Visus Therapeutics Investigative Site Recruiting
San Antonio, Texas, United States, 78229
Contact: C. Hazen    210-424-2584      
United States, Utah
Visus Therapeutics Investigative Site Recruiting
Draper, Utah, United States, 84020
Contact: M. Avila, MD    801-988-7346      
United States, Virginia
Visus Therapeutics Investigative Site Recruiting
Falls Church, Virginia, United States, 22046
Contact: K. Ng    202-239-0777      
Visus Therapeutics Investigative Site Recruiting
Lynchburg, Virginia, United States, 24502
Contact: C. Torrence    434-947-3984      
Sponsors and Collaborators
Visus Therapeutics
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Visus Therapeutics
ClinicalTrials.gov Identifier: NCT05135286    
Other Study ID Numbers: VT-003
First Posted: November 26, 2021    Key Record Dates
Last Update Posted: April 23, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Presbyopia
Refractive Errors
Eye Diseases
Brimonidine Tartrate
Carbachol
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
 Physiological Effects of Drugs
Cardiotonic Agents
Miotics
Autonomic Agents
Peripheral Nervous System Agents
Cholinergic Agonists
Cholinergic Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Protective Agents