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Cholinergic Agonist

BRIMOCHOL + Carbachol for Presbyopia

Phase 3
Waitlist Available
Research Sponsored by Visus Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must have presbyopia
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline day 1
Awards & highlights

Summary

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.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects from BRIMOCHOL™ PF and Carbachol PF may include temporary burning sensation in the eyes, headache, blurred vision, eye irritation or redness. The severity of side effects may vary among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I need reading glasses due to age.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline day 1
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline day 1 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline in near VA

Side effects data

From 2023 Phase 3 trial • 182 Patients • NCT05270863
11%
Eye Irritation
3%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Carbachol PF
BRIMOCHOL™ PF
Brimonidine Tartrate

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: BRIMOCHOL™ PFExperimental Treatment1 Intervention
A single drop in each eye at a visit.
Group II: Carbachol PFActive Control1 Intervention
A single drop in each eye at a visit.
Group III: VehiclePlacebo Group1 Intervention
A single drop in each eye at a visit.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brimonidine
FDA approved

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Presbyopia, such as Brimonidine and Carbachol, work through distinct mechanisms. Brimonidine reduces the production of aqueous humor and increases uveoscleral outflow, which helps manage intraocular pressure and is being explored for its potential benefits in Presbyopia. Carbachol stimulates muscarinic receptors to contract the ciliary muscle, improving near vision by enhancing the eye's ability to focus on close objects. These mechanisms are important for Presbyopia patients as they offer potential improvements in near vision, thereby enhancing daily activities and quality of life.
Effects of prostaglandin E2 and cholinergic drugs on intraocular pressure.The M4 muscarinic antagonist MT-3 inhibits myopia in chick: evidence for site of action.

Find a Location

Who is running the clinical trial?

Visus TherapeuticsLead Sponsor
2 Previous Clinical Trials
263 Total Patients Enrolled
2 Trials studying Presbyopia
263 Patients Enrolled for Presbyopia
~41 spots leftby Dec 2024