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Cholinergic Agonist

Safety and Efficacy Study BRIMOCHOL™ PF and Carbachol PF in Subjects With Emmetropic Phakic or Pseudophakic 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 hour 1
Awards & highlights
No Placebo-Only Group
Pivotal Trial

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.

Eligible Conditions
  • Presbyopia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 hour 1
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 hour 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
Proportion of Subjects With >=15 Letter Gain Without >=5 Letter Loss in Near Visual Acuity

Side effects data

From 2023 Phase 3 trial • 182 Patients • NCT05270863
1%
Eye Irritation
1%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Brimonidine Tartrate
BRIMOCHOL™ PF
Carbachol PF

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
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: Brimonidine tartrateActive Control1 Intervention
A single drop in each eye at a visit.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BRIMOCHOL™ PF
2022
Completed Phase 3
~190

Find a Location

Who is running the clinical trial?

Visus TherapeuticsLead Sponsor
2 Previous Clinical Trials
531 Total Patients Enrolled
2 Trials studying Presbyopia
531 Patients Enrolled for Presbyopia
~50 spots leftby Dec 2025
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