PresbyopiaPhase 3NCT05270863

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

A Phase 3 study testing BRIMOCHOL™ PF, Carbachol PF and Brimonidine tartrate in people with Presbyopia, run by Visus Therapeutics at 15 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Safety and Efficacy Study of BRIMOCHOL™ PF and Carbachol PF in Subjects With Emmetropic Phakic and Pseudophakic Presbyopia Read more about this study

Who is it for?: Ages 45 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Presbyopia
What is being tested?: BRIMOCHOL™ PF, Carbachol PF and Brimonidine tartrate
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 182 participants
Where: 15 sitesUnited States
Study dates: 30 Mar 2022to 10 Apr 2023
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 to 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Male or female in good general health
Must have presbyopia

Who cannot join

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

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

United States15 sites

Visus Therapeutics Investigative Site
Cedar Park, Texas, 78613
Visus Therapeutics Investigative Site
Glendale, California, 91204
Visus Therapeutics Investigative Site
Houston, Texas, 77027
Visus Therapeutics Investigative Site
Jacksonville, Florida, 32204
Visus Therapeutics Investigative Site
Kansas City, Missouri, 64133
Visus Therapeutics Investigative Site
Kansas City, Missouri, 64154
Visus Therapeutics Investigative Site
Memphis, Tennessee, 38119
Visus Therapeutics Investigative Site
Memphis, Tennessee, 77027
Visus Therapeutics Investigative Site
Morrow, Georgia, 30260
Visus Therapeutics Investigative Site
Ogden, Utah, 84403
Visus Therapeutics Investigative Site
Pittsburgh, Pennsylvania, 66762
Visus Therapeutics Investigative Site
Rancho Cordova, California, 95670
Visus Therapeutics Investigative Site
Roswell, Georgia, 30076
Visus Therapeutics Investigative Site
San Antonio, Texas, 78229
Visus Therapeutics Investigative Site
Shawnee Mission, Kansas, 66204

Other trials in United States

About this study

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

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

Read the 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

Conditions: Presbyopia
Being tested: BRIMOCHOL™ PF, Carbachol PF, Brimonidine tartrate
Medical subject headings: Presbyopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BRIMOCHOL™ PFDrug
Also called carbachol/brimonidine tartrate
A single drop in each eye at a visit.
Carbachol PFDrug
Also called carbachol monotherapy
A single drop in each eye at a visit.
Brimonidine tartrateDrug
Also called brimonidine tartrate monotherapy
A single drop in each eye at a visit.

Study groups in NCT05270863
Study group	Role	What they receive
BRIMOCHOL™ PF	Experimental	A single drop in each eye at a visit. Receives: Drug: BRIMOCHOL™ PF
Carbachol PF	Active comparator	A single drop in each eye at a visit. Receives: Drug: Carbachol PF
Brimonidine tartrate	Active comparator	A single drop in each eye at a visit. Receives: Drug: Brimonidine tartrate

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Day 1 Hour 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Mar 202210 Apr 2023

First posted8 Mar 2022
Study start30 Mar 2022
Primary completion17 Mar 2023
Study completion10 Apr 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PresbyopiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 182 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05270863
Sponsor's protocol ID: VT-002
Status last verified: Oct 2024
First submitted: 25 Feb 2022
Last updated: 15 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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VisDura VisAbility™ Micro Insert System Pre-market Clinical Trial
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Volumetric Visual Fields at Intermediate and Near Distances in Presbyopic Patients Using Occupational and General-Purpose Progressive Addition Lenses
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All Presbyopia trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05270863
Acronym / sponsor ID: VT-002
Conditions: Presbyopia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 182 participants (actual)
Lead sponsor: Visus TherapeuticsUniversity, hospital or other
Study start: 30 Mar 2022 (actual)
Primary completion: 17 Mar 2023 (actual)
Study completion: 10 Apr 2023 (actual)
First posted: 8 Mar 2022 (actual)
Results: Posted 5 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
BRIMOCHOL™ PF	Experimental	Drug: BRIMOCHOL™ PFA single drop in each eye at a visit.
Carbachol PF	Active comparator	Drug: Carbachol PFA single drop in each eye at a visit.
Brimonidine tartrate	Active comparator	Drug: Brimonidine tartrateA single drop in each eye at a visit.

Who may qualify

Ages: 45 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Male or female in good general health
Must have presbyopia

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BRIMOCHOL™ PFAlso: carbachol/brimonidine tartrateA single drop in each eye at a visit.	Drug	BRIMOCHOL™ PF
Carbachol PFAlso: carbachol monotherapyA single drop in each eye at a visit.	Drug	Carbachol PF
Brimonidine tartrateAlso: brimonidine tartrate monotherapyA single drop in each eye at a visit.	Drug	Brimonidine tartrate

Primary outcome

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

Results and safety

Results posted to the registry on 5 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
B, C, BF	31	31
B, BF, C	30	30
C, B, BF	30	30
C, BF, B	30	29
BF, B, C	31	31
BF, C, B	30	30

Primary outcome: Proportion of Subjects With >=15 Letter Gain Without >=5 Letter Loss in Near Visual Acuity

Time frame: Day 1 Hour 1. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	BRIMOCHOL™ PF n = 178	Carbachol PF n = 177	Brimonidine Tartrate n = 176
Value	49.4 (41.9 to 57.0)	35.0 (28.0 to 42.5)	22.7 (16.8 to 29.6)

BRIMOCHOL™ PF vs Carbachol PF vs Brimonidine Tartrate: p <.001, Regression, Logistic

Population analysed: All participants who received at least one dose of study treatment (mITT)

Adverse events

Time frame: 45 Days. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BRIMOCHOL™ PF	1 of 178 (0.6%)	37 of 178 (20.8%)	0 of 178
Carbachol PF	0 of 177 (0%)	24 of 177 (13.6%)	0 of 177
Brimonidine Tartrate	0 of 176 (0%)	2 of 176 (1.1%)	0 of 176

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Recruiting
Evaluation of Functional Superiority of the Morrow eProgressive
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Active, not recruiting
Clinical Trial With Artiflex Presbyopic (Artiplus)
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Recruiting
VisDura VisAbility™ Micro Insert System Pre-market Clinical Trial
Presbyopia
Recruiting
Volumetric Visual Fields at Intermediate and Near Distances in Presbyopic Patients Using Occupational and General-Purpose Progressive Addition Lenses
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Recruiting
Volumetric Visual Fields at Different Distances in Presbyopic Patients Using Occupational (PC-133 and PC-200) and General-Purpose Progressive Addition Lenses
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

15 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BRIMOCHOL™ PF, Carbachol PF and Brimonidine tartrate in people with Presbyopia, run by Visus Therapeutics at 15 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Subjects With >=15 Letter Gain Without >=5 Letter Loss in Near Visual Acuity (time frame: Day 1 Hour 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05270863.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.