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NCT05135286 | Recruiting | Presbyopia


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

Visus Therapeutics

Brief Summary:

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

Condition or disease

Presbyopia

Intervention/treatment

BRIMOCHOL™ PF

Carbachol PF

Vehicle

Phase

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 Type : Interventional
Estimated Enrollment : 450 participants
Masking: Double
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 : March 31, 2023
Estimated Study Completion Date : May 31, 2023
Arm Intervention/treatment

Experimental: BRIMOCHOL™ PF

A single drop in each eye at a visit.

Drug: BRIMOCHOL™ PF

Active Comparator: Carbachol PF

A single drop in each eye at a visit.

Drug: Carbachol PF

Placebo Comparator: Vehicle

A single drop in each eye at a visit.

Drug: Vehicle

Ages Eligible for Study: 45 Years to 80 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
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

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

Location Details


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

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Recruiting

United States, Arizona

Visus Therapeutics Investigative Site

Chandler, Arizona, United States, 85224

Recruiting

United States, Arizona

Visus Therapeutics Investigative Site

Phoenix, Arizona, United States, 85032

Recruiting

United States, Arizona

Visus Therapeutics Investigative Site

Sun City, Arizona, United States, 85351

Recruiting

United States, California

Visus Therapeutics Investigative Site

Glendale, California, United States, 91204

Recruiting

United States, California

Visus Therapeutics Investigative Site

Inglewood, California, United States, 90301

Recruiting

United States, California

Visus Therapeutics Investigative Site

Irvine, California, United States, 92604

Recruiting

United States, California

Visus Therapeutics Investigative Site

Mission Hills, California, United States, 91345

Recruiting

United States, California

Visus Therapeutics Investigative Site

Newport Beach, California, United States, 92663

Active, not recruiting

United States, California

Visus Therapeutics Investigative Site

Newport Beach, California, United States, 92663

Recruiting

United States, California

Visus Therapeutics Investigative Site

Pasadena, California, United States, 91107

Recruiting

United States, California

Visus Therapeutics Investigative Site

Santa Barbara, California, United States, 93105

Recruiting

United States, Colorado

Visus Therapeutics Investigative Site

Littleton, Colorado, United States, 80120

Recruiting

United States, Connecticut

Visus Therapeutics Investigative Site

Danbury, Connecticut, United States, 06810

Recruiting

United States, Florida

Visus Therapeutics Investigative Site

Crystal River, Florida, United States, 34429

Recruiting

United States, Florida

Visus Therapeutics Investigative Site

Delray Beach, Florida, United States, 33484

Recruiting

United States, Florida

Visus Therapeutics Investigative Site

Fort Lauderdale, Florida, United States, 33309

Recruiting

United States, Florida

Visus Therapeutics Investigative Site

Jacksonville, Florida, United States, 32256

Recruiting

United States, Florida

Visus Therapeutics Investigative Site

Largo, Florida, United States, 33770

Recruiting

United States, Florida

Visus Therapeutics Investigative Site

Mount Dora, Florida, United States, 32757

Recruiting

United States, Illinois

Visus Therapeutics Investigative Site

Lake Villa, Illinois, United States, 60046

Recruiting

United States, Indiana

Visus Therapeutics Investigative Site

Indianapolis, Indiana, United States, 46260

Recruiting

United States, Kentucky

Visus Therapeutics Investigative Site

Louisville, Kentucky, United States, 40206

Recruiting

United States, Minnesota

Visus Therapeutics Investigative Site

Bloomington, Minnesota, United States, 55420

Recruiting

United States, Missouri

Visus Therapeutics Investigative Site

Kansas City, Missouri, United States, 64111

Recruiting

United States, Missouri

Visus Therapeutics Investigative Site

Saint Louis, Missouri, United States, 63128

Recruiting

United States, Nevada

Visus Therapeutics Investigative Site

Henderson, Nevada, United States, 89502

Recruiting

United States, New York

Visus Therapeutics Investigative Site

Poughkeepsie, New York, United States, 12603

Recruiting

United States, North Carolina

Visus Therapeutics Investigative Site

Garner, North Carolina, United States, 27529

Recruiting

United States, North Dakota

Visus Therapeutics Investigative Site

W. Fargo, North Dakota, United States, 58078

Recruiting

United States, Ohio

Visus Therapeutics Investigative Site

Powell, Ohio, United States, 43065

Recruiting

United States, Oregon

Visus Therapeutics Investigative Site

Portland, Oregon, United States, 97210

Recruiting

United States, Pennsylvania

Visus Therapeutics Investigative Site

Cranberry Township, Pennsylvania, United States, 16066

Recruiting

United States, Pennsylvania

Visus Therapeutics Investigative Site

Wilkes-Barre, Pennsylvania, United States, 18702

Recruiting

United States, South Dakota

Visus Therapeutics Investigative Site

Sioux Falls, South Dakota, United States, 57108

Recruiting

United States, Tennessee

Visus Therapeutics Investigative Site

Maryville, Tennessee, United States, 37803

Recruiting

United States, Tennessee

Visus Therapeutics Investigative Site

Memphis, Tennessee, United States, 38119

Recruiting

United States, Tennessee

Visus Therapeutics Investigative Site

Smyrna, Tennessee, United States, 37167

Recruiting

United States, Texas

Visus Therapeutics Investigative Site

Hurst, Texas, United States, 76054

Recruiting

United States, Texas

Visus Therapeutics Investigative Site

Lakeway, Texas, United States, 78738

Recruiting

United States, Texas

Visus Therapeutics Investigative Site

San Antonio, Texas, United States, 78229

Recruiting

United States, Utah

Visus Therapeutics Investigative Site

Draper, Utah, United States, 84020

Recruiting

United States, Virginia

Visus Therapeutics Investigative Site

Falls Church, Virginia, United States, 22046

Recruiting

United States, Virginia

Visus Therapeutics Investigative Site

Lynchburg, Virginia, United States, 24502

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