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

NCT ID: NCT04774237

Last Updated: 2025-02-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-24

Study Completion Date

2021-10-19

Brief Summary

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Safety and Efficacy Study of BRIMOCHOL™ vs. BRIMOCHOL™ F vs. Carbachol Monotherapy Topical Ophthalmic Solutions in Subjects with Emmetropic Phakic and Pseudophakic Presbyopia

Detailed Description

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A 3-Dose, Multicenter, Randomized, Double-Masked, Crossover Phase 2 Safety and Efficacy Study of BRIMOCHOL™ Topical Ophthalmic Solution vs. BRIMOCHOL™ F Topical Ophthalmic Solution vs. Monotherapy with Carbachol Topical Ophthalmic Solution in Subjects with Emmetropic Phakic and Pseudophakic Presbyopia

Conditions

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Presbyopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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BRIMOCHOL™

A single drop in each eye at a visit.

Group Type EXPERIMENTAL

BRIMOCHOL™

Intervention Type DRUG

A single drop in each eye at a visit.

BRIMOCHOL™ F

A single drop in each eye at a visit.

Group Type EXPERIMENTAL

BRIMOCHOL™ F

Intervention Type DRUG

A single drop in each eye at a visit.

Carbachol

A single drop in each eye at a visit.

Group Type ACTIVE_COMPARATOR

Carbachol

Intervention Type DRUG

A single drop in each eye at a visit.

Interventions

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BRIMOCHOL™

A single drop in each eye at a visit.

Intervention Type DRUG

BRIMOCHOL™ F

A single drop in each eye at a visit.

Intervention Type DRUG

Carbachol

A single drop in each eye at a visit.

Intervention Type DRUG

Other Intervention Names

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carbachol/brimonidine tartrate 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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Global Research Management, Inc.

Glendale, California, United States

Site Status

Eye Research Foundation

Newport Beach, California, United States

Site Status

Total Eye Care, PA

Memphis, Tennessee, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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VT-001

Identifier Type: -

Identifier Source: org_study_id

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