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Cholinergic Agonist

BRIMOCHOL™ PF for Presbyopia

Phase 3
Recruiting
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

Study Summary

This trial will study the safety and efficacy of two drugs, BRIMOCHOL and Carbachol, in subjects with presbyopia.

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.Check my eligibility
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.See study design
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in near VA

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

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In how many different locations are these tests being conducted?

"To make the study more accessible to patients, it is being conducted out of 42 sites. These locations include Glendale, Hurst, Henderson, and other places. By selecting the site closest to you, you can minimize travel requirements."

Answered by AI

Does the research on BRIMOCHOL™ stand up to scrutiny?

"BRIMOCHOL's™ efficacy was first explored in 2021 by Allegisa. Since then, there have been 300 completed clinical trials. At the moment, 3 such studies are ongoing, with a majority of these taking place in Glendale, California."

Answered by AI

What is the BRIMOCHOL™ regulatory status in the United States?

"BRIMOCHOL™ is rated 3 out of 3 in terms of safety by our analysts at Power. This is because BRIMOCHOL™ is in Phase 3 of clinical trials, which suggests that there is both evidence of efficacy and multiple rounds of data supporting safety."

Answered by AI

For what purpose is BRIMOCHOL™ most often taken by patients?

"BRIMOCHOL™ can help patients who have unsuccessfully tried to control their intraocular pressure or who have open angle glaucoma or glaucoma."

Answered by AI

Does the age limit for this trial exclude people in their thirties and younger?

"The age range for people who are eligible for this clinical trial are between 45-80 years old."

Answered by AI

What is the total projected number of individuals that will be included in this clinical research?

"That is correct, the online clinicaltrials.gov registry shows that this study is looking for new patients. It was first posted on March 15th, 2022 and was last updated September 30th, 2022. In total, they are hoping to enroll 450 people at 42 different sites."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
Nevada
California
What site did they apply to?
Visus Therapeutics Investigative Site
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

What questions have other patients asked about this trial?

Recent research and studies
clinicaltrials.govStudy
Safety and Efficacy Study of BRIMOCHOL™ PF and Carbachol PF in Subjects With Emmetropic Phakic and Pseudophakic Presbyopia
2022. "Safety and Efficacy Study of BRIMOCHOL™ PF and Carbachol PF in Subjects With Emmetropic Phakic and Pseudophakic Presbyopia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05135286.
All > Presbyopia
~109 spots leftby Dec 2024
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