PresbyopiaPhase 2NCT04774237
Safety and Efficacy Study of BRIMOCHOL™, BRIMOCHOL™ F, and Carbachol in Subjects With Emmetropic Phakic and Pseudophakic Presbyopia
A Phase 2 study testing BRIMOCHOL™, BRIMOCHOL™ F and Carbachol in people with Presbyopia, run by Visus Therapeutics at 3 sites in United States.
Trial summary
Safety and Efficacy Study of BRIMOCHOL™ vs. BRIMOCHOL™ F vs. Carbachol Monotherapy Topical Ophthalmic Solutions 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™, BRIMOCHOL™ F and Carbachol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 3 sitesUnited States
- Study dates
- 24 Mar 2021to 19 Oct 2021
- Phase
- Phase 2
- 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
3 sites in 1 country.
United States3 sites
Global Research Management, Inc.
Glendale, California, 91204
Total Eye Care, PA
Memphis, Tennessee, 38119
Eye Research Foundation
Newport Beach, California, 92663
About this study
Official title: 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
Safety and Efficacy Study of BRIMOCHOL™ vs. BRIMOCHOL™ F vs. Carbachol Monotherapy Topical Ophthalmic Solutions in Subjects with Emmetropic Phakic and Pseudophakic Presbyopia
Read the detailed description
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
- Presbyopia
- Being tested
- BRIMOCHOL™, BRIMOCHOL™ F, Carbachol
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BRIMOCHOL™Drug
Also called carbachol/brimonidine tartrate
A single drop in each eye at a visit.
BRIMOCHOL™ FDrug
Also called carbachol/brimonidine tartrate
A single drop in each eye at a visit.
CarbacholDrug
Also called carbachol monotherapy
A single drop in each eye at a visit.
| Study group | Role | What they receive |
|---|---|---|
| BRIMOCHOL™ | Experimental | A single drop in each eye at a visit. Receives: Drug: BRIMOCHOL™ |
| BRIMOCHOL™ F | Experimental | A single drop in each eye at a visit. Receives: Drug: BRIMOCHOL™ F |
| Carbachol | Active comparator | A single drop in each eye at a visit. Receives: Drug: Carbachol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Subjects With a >=15 Letter Gain Without a < 5 Letter Loss in Near Visual Acuity
Primary Endpoint measured at Hour 1 post-dose at Study Visit - a Single drop Cohort
Measured: Day 1, Hour 1 post-dose
Secondary outcomes (1)
Change From Baseline ETDRS Letters Score in Distance Visual Acuity
Secondary Endpoint measured at Hour 1 post-dose at Study Visit - a Single drop Cohort
Measured: Day 1, Hour 1 post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start24 Mar 2021
- Primary completion19 Oct 2021
- Study completion19 Oct 2021
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 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
- NCT04774237
- Sponsor's protocol ID
- VT-001
- Status last verified
- Mar 2026
- First submitted
- 23 Feb 2021
- Last updated
- 27 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04774237
- Acronym / sponsor ID
- VT-001
- Conditions
- Presbyopia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Visus TherapeuticsUniversity, hospital or other
- Study start
- 24 Mar 2021 (actual)
- Primary completion
- 19 Oct 2021 (actual)
- Study completion
- 19 Oct 2021 (actual)
- First posted
- 1 Mar 2021 (actual)
- Results
- Posted 5 Feb 2025
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™ vs. BRIMOCHOL™ F vs. Carbachol Monotherapy Topical Ophthalmic Solutions in Subjects with Emmetropic Phakic and Pseudophakic Presbyopia
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BRIMOCHOL™ | Experimental | Drug: BRIMOCHOL™A single drop in each eye at a visit. |
| BRIMOCHOL™ F | Experimental | Drug: BRIMOCHOL™ FA single drop in each eye at a visit. |
| Carbachol | Active comparator | Drug: CarbacholA 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™Also: carbachol/brimonidine tartrateA single drop in each eye at a visit. | Drug | BRIMOCHOL™ |
| BRIMOCHOL™ FAlso: carbachol/brimonidine tartrateA single drop in each eye at a visit. | Drug | BRIMOCHOL™ F |
| CarbacholAlso: carbachol monotherapyA single drop in each eye at a visit. | Drug | Carbachol |
Primary outcome
Proportion of Subjects With a >=15 Letter Gain Without a < 5 Letter Loss in Near Visual Acuity
Time frame: Day 1, Hour 1 post-dose
Primary Endpoint measured at Hour 1 post-dose at Study Visit - a Single drop Cohort
1 secondary outcome
Change From Baseline ETDRS Letters Score in Distance Visual Acuity
Time frame: Day 1, Hour 1 post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BRIMOCHOL™, BRIMOCHOL™ F and Carbachol in people with Presbyopia, run by Visus Therapeutics at 3 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 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Feb 2025). 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 a >=15 Letter Gain Without a < 5 Letter Loss in Near Visual Acuity (time frame: Day 1, Hour 1 post-dose). 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 27 Mar 2026.