NCT05135286|CompletedPhase 3FDA Drug

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

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

Visus Therapeutics ClinicalTrials.gov

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1 other identifier

VT-003

Study Type

interventional

Target

629

Locations

1 country

Sites

Timeline

RegisteredNov 2021

StartedMar 2022

CompletionMar 2025

Brief Summary

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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

629

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Mar 2022

Typical duration for phase_3

Geographic Reach

1 country

42 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3 years study duration

First Submitted

Initial submission to the registry

November 4, 2021

Completed

22 days until next milestone

First Posted

Study publicly available on registry

November 26, 2021

Completed

4 months until next milestone

Study Start

First participant enrolled

March 15, 2022

Completed

3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2025

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2025

Completed

Last Updated

August 6, 2025

Status Verified

July 1, 2025

Enrollment Period

3 years

First QC Date

November 4, 2021

Last Update Submit

July 31, 2025

Conditions

Presbyopia

Outcome Measures

Primary Outcomes (1)

Change from baseline in near VA
Percentage of subjects with 3-line improvement in near VA without the loss of at least 1 line in distance VA
Baseline Day 1

Study Arms (3)

BRIMOCHOL™ PF

EXPERIMENTAL

A single drop in each eye at a visit.

Drug: BRIMOCHOL™ PF

Carbachol PF

ACTIVE COMPARATOR

A single drop in each eye at a visit.

Drug: Carbachol PF

Vehicle

PLACEBO COMPARATOR

A single drop in each eye at a visit.

Drug: Vehicle

Interventions

BRIMOCHOL™ PFDRUG

A single drop in each eye at a visit.

Also known as: carbachol/brimonidine tartrate

BRIMOCHOL™ PF

Carbachol PFDRUG

A single drop in each eye at a visit.

Also known as: carbachol monotherapy

Carbachol PF

VehicleDRUG

A single drop in each eye at a visit.

Vehicle

Eligibility Criteria

Age45 Years - 80 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Male or female in good general health
Must have presbyopia

You may not qualify if:

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

Contact the study team to confirm eligibility.