BRIMOCHOL + Carbachol for Presbyopia

Recruiting at 42 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

450 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests eye drops called BRIMOCHOL™ PF and Carbachol PF. It targets people who have trouble seeing things up close due to aging. The drops aim to improve their close-up vision by working on the eye's muscles or structures.

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 BRIMOCHOL + Carbachol safe for humans?

The combination of carbachol and brimonidine has been studied for presbyopia, with common side effects including headaches and dim vision at night. There is no known long-term safety data, but the treatment is considered to have a lower risk of serious eye-related side effects. ^{1 2 3 4 5}

How is the BRIMOCHOL + Carbachol drug different from other presbyopia drugs?

BRIMOCHOL + Carbachol is unique because it combines a parasympathomimetic drug (carbachol) and an alpha agonist (brimonidine) to create a pinhole effect that improves near vision without affecting distance vision. This combination aims to reduce presbyopia symptoms by enhancing the depth of focus through miosis (pupil constriction), offering a potential alternative to glasses or contact lenses. ^{1 2 3 5 6}

What data supports the effectiveness of the drug BRIMOCHOL™ PF and Carbachol PF for presbyopia?

Research suggests that using carbachol, a parasympathomimetic drug, with brimonidine, an alpha agonist, can help improve vision in presbyopia by creating a pinhole effect that increases focus. This combination has been tested in both combined and separate forms, showing potential for improving near vision without affecting distance vision. ^{1 2 3 5 6}

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. United States pubmed.ncbi.nlm.nih.gov

Improved Presbyopic Vision With Miotics. [2015]

2. England pubmed.ncbi.nlm.nih.gov

Clinical outcomes of combined versus separate carbachol and brimonidine drops in correcting presbyopia. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Pharmacological Strategies for Presbyopia Correction. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Presbyopia: a new potential pharmacological treatment. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Pharmacological Treatment in Presbyopia. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Efficacy of atropine 0.01% for the treatment of childhood myopia in European patients. [2023]