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

NCT ID: NCT05135286

Last Updated: 2025-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

629 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-15

Study Completion Date

2025-03-13

Brief Summary

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

Detailed Description

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Multicenter, Double-Masked, Randomized, Safety and Efficacy Study of BRIMOCHOL™ PF and Carbachol PF Topical Ophthalmic Solution With Emmetropic Phakic and Pseudophakic Presbyopia

Conditions

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Presbyopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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BRIMOCHOL™ PF

A single drop in each eye at a visit.

Group Type EXPERIMENTAL

BRIMOCHOL™ PF

Intervention Type DRUG

A single drop in each eye at a visit.

Carbachol PF

A single drop in each eye at a visit.

Group Type ACTIVE_COMPARATOR

Carbachol PF

Intervention Type DRUG

A single drop in each eye at a visit.

Vehicle

A single drop in each eye at a visit.

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type DRUG

A single drop in each eye at a visit.

Interventions

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BRIMOCHOL™ PF

A single drop in each eye at a visit.

Intervention Type DRUG

Carbachol PF

A single drop in each eye at a visit.

Intervention Type DRUG

Vehicle

A single drop in each eye at a visit.

Intervention Type DRUG

Other Intervention Names

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carbachol/brimonidine tartrate carbachol monotherapy

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Visus Therapeutics

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Visus Therapeutics Investigative Site

Chandler, Arizona, United States

Site Status

Visus Therapeutics Investigative Site

Phoenix, Arizona, United States

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Visus Therapeutics Investigative Site

Sun City, Arizona, United States

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Visus Therapeutics Investigative Site

Glendale, California, United States

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Visus Therapeutics Investigative Site

Inglewood, California, United States

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Visus Therapeutics Investigative Site

Irvine, California, United States

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Visus Therapeutics Investigative Site

Mission Hills, California, United States

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Visus Therapeutics Investigative Site

Newport Beach, California, United States

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Visus Therapeutics Investigative Site

Pasadena, California, United States

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Visus Therapeutics Investigative Site

Santa Barbara, California, United States

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Visus Therapeutics Investigative Site

Littleton, Colorado, United States

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Visus Therapeutics Investigative Site

Danbury, Connecticut, United States

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Visus Therapeutics Investigative Site

Crystal River, Florida, United States

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Visus Therapeutics Investigative Site

Delray Beach, Florida, United States

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Visus Therapeutics Investigative Site

Fort Lauderdale, Florida, United States

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Visus Therapeutics Investigative Site

Jacksonville, Florida, United States

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Visus Therapeutics Investigative Site

Largo, Florida, United States

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Visus Therapeutics Investigative Site

Mt. Dora, Florida, United States

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Visus Therapeutics Investigative Site

Lake Villa, Illinois, United States

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Visus Therapeutics Investigative Site

Indianapolis, Indiana, United States

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Visus Therapeutics Investigative Site

Louisville, Kentucky, United States

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Visus Therapeutics Investigative Site

Bloomington, Minnesota, United States

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Visus Therapeutics Investigative Site

Kansas City, Missouri, United States

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Visus Therapeutics Investigative Site

St Louis, Missouri, United States

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Visus Therapeutics Investigative Site

Henderson, Nevada, United States

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Visus Therapeutics Investigative Site

Poughkeepsie, New York, United States

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Garner, North Carolina, United States

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Visus Therapeutics Investigative Site

West Fargo, North Dakota, United States

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Visus Therapeutics Investigative Site

Powell, Ohio, United States

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Visus Therapeutics Investigative Site

Portland, Oregon, United States

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Visus Therapeutics Investigative Site

Cranberry Township, Pennsylvania, United States

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Visus Therapeutics Investigative Site

Wilkes-Barre, Pennsylvania, United States

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Visus Therapeutics Investigative Site

Sioux Falls, South Dakota, United States

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Visus Therapeutics Investigative Site

Maryville, Tennessee, United States

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Memphis, Tennessee, United States

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Visus Therapeutics Investigative Site

Smyrna, Tennessee, United States

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Visus Therapeutics Investigative Site

Hurst, Texas, United States

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Visus Therapeutics Investigative Site

Lakeway, Texas, United States

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Visus Therapeutics Investigative Site

San Antonio, Texas, United States

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Visus Therapeutics Investigative Site

Draper, Utah, United States

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Visus Therapeutics Investigative Site

Falls Church, Virginia, United States

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Visus Therapeutics Investigative Site

Lynchburg, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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VT-003

Identifier Type: -

Identifier Source: org_study_id

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