NCT05270863|CompletedPhase 3ResultsFDA Drug

Safety and Efficacy Study BRIMOCHOL™ PF and Carbachol PF in Subjects With Emmetropic Phakic or 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-002

Study Type

interventional

Target

182

Locations

1 country

Sites

Timeline

RegisteredMar 2022

StartedMar 2022

CompletionApr 2023

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

182

participants targeted

Target at P25-P50 for phase_3

Timeline

Completed

Started Mar 2022

Shorter than P25 for phase_3

Geographic Reach

1 country

15 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

1 year study duration

First Submitted

Initial submission to the registry

February 25, 2022

Completed

11 days until next milestone

First Posted

Study publicly available on registry

March 8, 2022

Completed

22 days until next milestone

Study Start

First participant enrolled

March 30, 2022

Completed

12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2023

Completed

24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2023

Completed

1.4 years until next milestone

Results Posted

Study results publicly available

September 5, 2024

Completed

Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

12 months

First QC Date

February 25, 2022

Results QC Date

May 23, 2024

Last Update Submit

October 1, 2024

Conditions

Presbyopia

Outcome Measures

Primary Outcomes (1)

Proportion of Subjects With >=15 Letter Gain Without >=5 Letter Loss in Near Visual Acuity
Primary endpoint measure at hour 1 post-dose at study visit
Day 1 Hour 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

Brimonidine tartrate

ACTIVE COMPARATOR

A single drop in each eye at a visit.

Drug: Brimonidine tartrate

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

Brimonidine tartrateDRUG

A single drop in each eye at a visit.

Also known as: brimonidine tartrate monotherapy

Brimonidine tartrate

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.