BRIMOCHOL + Carbachol for Presbyopia

No longer recruiting at 45 trial locations

Overseen By David Le

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Visus Therapeutics

Disqualifiers: Allergic reactions, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatments, BRIMOCHOL™ PF and Carbachol PF (both eye drops), to evaluate their safety and effectiveness for individuals with presbyopia, a condition that causes difficulty in seeing things up close. Participants will receive either one of the treatments or a placebo, a substance with no active medicine, to determine which works best. The trial seeks individuals with presbyopia who are otherwise in good health. As a Phase 3 trial, this is the final step before FDA approval, offering participants the opportunity to contribute to the development of a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that BRIMOCHOL™ PF is generally safe. In a 12-month study, participants tolerated it well, and no serious side effects related to the treatment occurred. This suggests most people can use it without problems.

Carbachol PF's active ingredients have been used safely in other treatments for a long time, providing extensive knowledge about its safety. Previous research has demonstrated the safety of both treatments in the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about BRIMOCHOL™ PF and Carbachol PF for presbyopia because these treatments offer a fresh approach to managing this common age-related condition. Unlike traditional treatments that often require reading glasses or invasive procedures, these eye drops could provide a non-surgical option by improving near vision through pharmacological means. BRIMOCHOL™ PF is particularly noteworthy for its combination of brimonidine and carbachol in a preservative-free formula, potentially reducing side effects and irritation compared to other medicated drops. This innovative approach could make daily activities easier for people with presbyopia, offering a convenient and quick-acting solution.

What evidence suggests that this trial's treatments could be effective for presbyopia?

In this trial, participants will receive either BRIMOCHOL PF or Carbachol PF. A previous study showed that BRIMOCHOL PF helps people with presbyopia (difficulty seeing things up close as you age) improve their near vision for about 8 to 10 hours. About 85% of users could see clearly enough to read within an hour. Research has shown that BRIMOCHOL PF also helps people read faster and enhances their quality of life. For Carbachol PF, studies found it significantly improved near vision for users. Both treatments have shown promising results in helping people with presbyopia see things up close more easily. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for men and women in good health who have presbyopia, a condition that affects near vision typically in middle age. It's open to those with natural lens (phakic) or artificial lens implants (pseudophakic). People can't join if they have other medical conditions that could interfere with the study or are allergic to the drugs being tested.

Inclusion Criteria

I am in good health overall.

I need reading glasses due to age.

Exclusion Criteria

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

History of allergic reaction to the study drug or any of its components

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single drop of BRIMOCHOL™ PF, Carbachol PF, or Vehicle in each eye at a visit

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BRIMOCHOL™ PF
• Carbachol PF

Trial Overview The study is testing BRIMOCHOL™ PF and Carbachol PF eye drops against a placebo (vehicle) to see which is better at improving near vision in people with presbyopia. Participants will be randomly assigned to receive one of these treatments.

How Is the Trial Designed?

Group I: BRIMOCHOL™ PF Experimental Treatment 1 Intervention

A single drop in each eye at a visit.

Group II: Carbachol PF Active Control 1 Intervention

A single drop in each eye at a visit.

Group III: Vehicle Placebo Group 1 Intervention

A single drop in each eye at a visit.

Who Is Running the Clinical Trial?

Visus Therapeutics

Lead Sponsor

Trials

3

Recruited

650+

Published Research Related to This Trial

A proposed treatment for presbyopia in people over 40 involves using a combination of a cholinergic agent and non-steroidal anti-inflammatory drugs (NSAIDs) to improve near vision without impacting distance vision.

The treatment is designed to stimulate the ciliary muscle and iris through muscarinic receptors, and it is formulated to avoid any inflammatory or adverse side effects, making it a potentially safe option for correcting accommodation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Presbyopia: a new potential pharmacological treatment. Benozzi, J., Benozzi, G., Orman, B.[2021]

Citations

1. crstoday.com crstoday.com/articles/sept-2025/brimochol-pf-for-presbyopia

BRIMOCHOL ™ PF for Presbyopia A single drop of BRIMOCHOL PF offers 8–10 hours of improved near vision, with 85% of subjects achieving 20/40 vision or better within 1 hour, and nearly 50% ...

2. touchophthalmology.com touchophthalmology.com/insight/phase-3-brio-ii-study-confirms-brimochol-pfs-effectiveness-for-presbyopia-treatment/

Phase 3 BRIO-II study confirms BRIMOCHOL™ PF's ... Additional analyses revealed that BRIMOCHOL™ PF significantly improved reading speed and patient-reported quality of life outcomes, as measured ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05270863?term=NCT04774237%20NCT05135286%20NCT05270863&rank=1&tab=results

NCT05270863 | Safety and Efficacy Study BRIMOCHOL™ ... Safety and Efficacy Study BRIMOCHOL™ PF and Carbachol PF in Subjects With Emmetropic Phakic or Pseudophakic Presbyopia. ClinicalTrials.gov ID NCT05270863.

4. presbyopiaphysician.com presbyopiaphysician.com/issues/2024/september/an-update-on-brimochol-pf/

An Update on Brimochol PF With the data from this clinical trial expected in late 2024, Brimochol PF is likely to be the fourth presbyopia-correcting drop to market.

5. hcplive.com hcplive.com/view/brimochol-pf-achieves-durable-near-vision-improvement-in-presbyopia

BRIMOCHOL PF Achieves Durable Near Vision ... - HCPLive BRIMOCHOL PF showed durable improvement in near vision for presbyopia patients over 12 months without drug-waning effects. The Phase 3 BRIO-II ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05135286

NCT05135286 | Safety and Efficacy Study of BRIMOCHOL ... Safety and Efficacy Study of BRIMOCHOL™ PF and Carbachol PF in Subjects With Emmetropic Phakic and Pseudophakic Presbyopia. Detailed Description. Multicenter ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05270863

NCT05270863 | Safety and Efficacy Study BRIMOCHOL™ ... Inclusion Criteria: Male or female in good general health; Must have presbyopia. Exclusion Criteria: History of allergic reaction to the study drug or any ...

8. optometryadvisor.com optometryadvisor.com/news/tenpoint-therapeutics-brimochol-presbyopia-drop-submitted-to-fda-for-new-drug-application/

Brimochol Presbyopia Drop Submitted For New Drug ... The treatment showed a favorable safety and tolerability profile, with no serious treatment-related adverse events reported during the study.