Safety and Efficacy Study of BRIMOCHOL™, BRIMOCHOL™ F, and Carbachol in Subjects With Emmetropic Phakic and Pseudophakic Presbyopia
A 3-Dose, Multicenter, Randomized, Double-Masked, Crossover Phase 2 Safety and Efficacy Study of BRIMOCHOL™ Topical Ophthalmic Solution vs. BRIMOCHOL™ F Topical Ophthalmic Solution vs. Monotherapy With Carbachol Topical Ophthalmic Solution in Subjects With Emmetropic Phakic and Pseudophakic Presbyopia
1 other identifier
interventional
18
1 country
3
Brief Summary
Safety and Efficacy Study of BRIMOCHOL™ vs. BRIMOCHOL™ F vs. Carbachol Monotherapy Topical Ophthalmic Solutions in Subjects with Emmetropic Phakic and Pseudophakic Presbyopia
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Mar 2021
Shorter than P25 for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 23, 2021
CompletedFirst Posted
Study publicly available on registry
March 1, 2021
CompletedStudy Start
First participant enrolled
March 24, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 19, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 19, 2021
CompletedResults Posted
Study results publicly available
February 5, 2025
CompletedMarch 27, 2026
March 1, 2026
7 months
February 23, 2021
October 10, 2024
March 6, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of Subjects With a >=15 Letter Gain Without a < 5 Letter Loss in Near Visual Acuity
Primary Endpoint measured at Hour 1 post-dose at Study Visit - a Single drop Cohort
Day 1, Hour 1 post-dose
Secondary Outcomes (1)
Change From Baseline ETDRS Letters Score in Distance Visual Acuity
Day 1, Hour 1 post-dose
Study Arms (3)
BRIMOCHOL™
EXPERIMENTALA single drop in each eye at a visit.
BRIMOCHOL™ F
EXPERIMENTALA single drop in each eye at a visit.
Carbachol
ACTIVE COMPARATORA single drop in each eye at a visit.
Interventions
A single drop in each eye at a visit.
A single drop in each eye at a visit.
Eligibility Criteria
You may qualify if:
- Male or female in good general health
- Must have presbyopia
You may not qualify if:
- History of allergic reaction to the study drug or any of its components
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Global Research Management, Inc.
Glendale, California, 91204, United States
Eye Research Foundation
Newport Beach, California, 92663, United States
Total Eye Care, PA
Memphis, Tennessee, 38119, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Visus Therapeutics
- Organization
- Visus Therapeutics, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2021
First Posted
March 1, 2021
Study Start
March 24, 2021
Primary Completion
October 19, 2021
Study Completion
October 19, 2021
Last Updated
March 27, 2026
Results First Posted
February 5, 2025
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share