PresbyopiaPhase 3NCT05135286
Safety and Efficacy Study of BRIMOCHOL™ PF and Carbachol PF in Subjects With Emmetropic Phakic and Pseudophakic Presbyopia
A Phase 3 study testing BRIMOCHOL™ PF and Carbachol PF in people with Presbyopia, run by Visus Therapeutics at 42 sites in United States.
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 and Carbachol PF
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 629 participants
- Where
- 42 sitesUnited States
- Study dates
- 15 Mar 2022to 13 Mar 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
42 sites in 1 country.
42 sites in 1 country
United States42 sites
Visus Therapeutics Investigative Site
Bloomington, Minnesota, 55420
Visus Therapeutics Investigative Site
Chandler, Arizona, 85224
Visus Therapeutics Investigative Site
Cranberry Township, Pennsylvania, 16066
Visus Therapeutics Investigative Site
Crystal River, Florida, 34429
Visus Therapeutics Investigative Site
Danbury, Connecticut, 06810
Visus Therapeutics Investigative Site
Delray Beach, Florida, 33484
Visus Therapeutics Investigative Site
Draper, Utah, 84020
Visus Therapeutics Investigative Site
Falls Church, Virginia, 22046
Visus Therapeutics Investigative Site
Fort Lauderdale, Florida, 33309
Visus Therapeutics Investigative Site
Garner, North Carolina, 27529
Visus Therapeutics Investigative Site
Glendale, California, 91204
Visus Therapeutics Investigative Site
Henderson, Nevada, 89502
Visus Therapeutics Investigative Site
Hurst, Texas, 76054
Visus Therapeutics Investigative Site
Indianapolis, Indiana, 46260
Visus Therapeutics Investigative Site
Inglewood, California, 90301
Visus Therapeutics Investigative Site
Irvine, California, 92604
Visus Therapeutics Investigative Site
Jacksonville, Florida, 32256
Visus Therapeutics Investigative Site
Kansas City, Missouri, 64111
Visus Therapeutics Investigative Site
Lake Villa, Illinois, 60046
Visus Therapeutics Investigative Site
Lakeway, Texas, 78738
Visus Therapeutics Investigative Site
Largo, Florida, 33770
Visus Therapeutics Investigative Site
Littleton, Colorado, 80120
Visus Therapeutics Investigative Site
Louisville, Kentucky, 40206
Visus Therapeutics Investigative Site
Lynchburg, Virginia, 24502
Visus Therapeutics Investigative Site
Maryville, Tennessee, 37803
Visus Therapeutics Investigative Site
Memphis, Tennessee, 38119
Visus Therapeutics Investigative Site
Mission Hills, California, 91345
Visus Therapeutics Investigative Site
Mt. Dora, Florida, 32757
Visus Therapeutics Investigative Site
Newport Beach, California, 92663
Visus Therapeutics Investigative Site
Pasadena, California, 91107
Visus Therapeutics Investigative Site
Phoenix, Arizona, 85032
Visus Therapeutics Investigative Site
Portland, Oregon, 97210
Visus Therapeutics Investigative Site
Poughkeepsie, New York, 12603
Visus Therapeutics Investigative Site
Powell, Ohio, 43065
Visus Therapeutics Investigative Site
San Antonio, Texas, 78229
Visus Therapeutics Investigative Site
Santa Barbara, California, 93105
Visus Therapeutics Investigative Site
Sioux Falls, South Dakota, 57108
Visus Therapeutics Investigative Site
Smyrna, Tennessee, 37167
Visus Therapeutics Investigative Site
St Louis, Missouri, 63128
Visus Therapeutics Investigative Site
Sun City, Arizona, 85351
Visus Therapeutics Investigative Site
West Fargo, North Dakota, 58078
Visus Therapeutics Investigative Site
Wilkes-Barre, Pennsylvania, 18702
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, Vehicle
- 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.
VehicleDrug
A single drop in each eye at a visit.
| 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 |
| Vehicle | Placebo comparator | A single drop in each eye at a visit. Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study start15 Mar 2022
- Primary completion13 Mar 2025
- Study completion13 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 629 participants (actual)
Sponsor and investigators
- Lead sponsor
- Visus Therapeutics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05135286
- Sponsor's protocol ID
- VT-003
- Status last verified
- Jul 2025
- First submitted
- 4 Nov 2021
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. 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
- NCT05135286
- Acronym / sponsor ID
- VT-003
- Conditions
- Presbyopia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 629 participants (actual)
- Lead sponsor
- Visus TherapeuticsUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 13 Mar 2025 (actual)
- Study completion
- 13 Mar 2025 (actual)
- First posted
- 26 Nov 2021 (actual)
- Results
- Not posted in the source record
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
- Parallel groups
- 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. |
| Vehicle | Placebo comparator | Drug: VehicleA 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 |
| VehicleA single drop in each eye at a visit. | Drug | Vehicle |
Primary outcome
Change from baseline in near VA
Time frame: Baseline Day 1
Percentage of subjects with 3-line improvement in near VA without the loss of at least 1 line in distance VA
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- Individual participant dataSharing planned: No
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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.
42 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 and Carbachol PF in people with Presbyopia, run by Visus Therapeutics at 42 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 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline in near VA (time frame: Baseline Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Aug 2025.