Back to resultsSafety and Efficacy Study of BRIMOCHOL™, BRIMOCHOL™ F, and Carbachol in Subjects With Emmetropic Phakic and Pseudophakic Presbyopia
Primary Purpose
Presbyopia
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
BRIMOCHOL™
BRIMOCHOL™ F
Carbachol
Sponsored by
About this trial
This is an interventional treatment trial for Presbyopia
Eligibility Criteria
Inclusion Criteria:
- Male or female in good general health
- Must have presbyopia
Exclusion Criteria:
- 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
Sites / Locations
- Global Research Management, Inc.
- Eye Research Foundation
- Total Eye Care, PA
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
BRIMOCHOL™
BRIMOCHOL™ F
Carbachol
Arm Description
A single drop in each eye at a visit.
A single drop in each eye at a visit.
A single drop in each eye at a visit.
Outcomes
Primary Outcome Measures
Change from baseline in near VA
Percentage of subjects with 3-line gains in near VA at various time points
Secondary Outcome Measures
Change from baseline in distance VA
Percentage of subjects with 1-line loss in distance VA at various time points
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04774237
Brief Title
Safety and Efficacy Study of BRIMOCHOL™, BRIMOCHOL™ F, and Carbachol in Subjects With Emmetropic Phakic and Pseudophakic Presbyopia
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
March 24, 2021 (Actual)
Primary Completion Date
October 19, 2021 (Actual)
Study Completion Date
October 19, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Visus Therapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
Detailed Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbyopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BRIMOCHOL™
Arm Type
Experimental
Arm Description
A single drop in each eye at a visit.
Arm Title
BRIMOCHOL™ F
Arm Type
Experimental
Arm Description
A single drop in each eye at a visit.
Arm Title
Carbachol
Arm Type
Active Comparator
Arm Description
A single drop in each eye at a visit.
Intervention Type
Drug
Intervention Name(s)
BRIMOCHOL™
Other Intervention Name(s)
carbachol/brimonidine tartrate
Intervention Description
A single drop in each eye at a visit.
Intervention Type
Drug
Intervention Name(s)
BRIMOCHOL™ F
Other Intervention Name(s)
carbachol/brimonidine tartrate
Intervention Description
A single drop in each eye at a visit.
Intervention Type
Drug
Intervention Name(s)
Carbachol
Other Intervention Name(s)
carbachol monotherapy
Intervention Description
A single drop in each eye at a visit.
Primary Outcome Measure Information:
Title
Change from baseline in near VA
Description
Percentage of subjects with 3-line gains in near VA at various time points
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Change from baseline in distance VA
Description
Percentage of subjects with 1-line loss in distance VA at various time points
Time Frame
From baseline through hour 9 at each study visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male or female in good general health
Must have presbyopia
Exclusion Criteria:
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
Facility Information:
Facility Name
Global Research Management, Inc.
City
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
Facility Name
Eye Research Foundation
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Total Eye Care, PA
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Safety and Efficacy Study of BRIMOCHOL™, BRIMOCHOL™ F, and Carbachol in Subjects With Emmetropic Phakic and Pseudophakic Presbyopia
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