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Safety and Efficacy Study BRIMOCHOL™ PF and Carbachol PF in Subjects With Emmetropic Phakic or Pseudophakic Presbyopia

Primary Purpose

Presbyopia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
BRIMOCHOL™ PF
Carbachol PF
Brimonidine tartrate
Sponsored by
Visus Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Presbyopia

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

  • Visus Therapeutics Investigative Site
  • Visus Therapeutics Investigative Site
  • Visus Therapeutics Investigative Site
  • Visus Therapeutics Investigative Site
  • Visus Therapeutics Investigative Site
  • Visus Therapeutics Investigative Site
  • Visus Therapeutics Investigative Site
  • Visus Therapeutics Investigative Site
  • Visus Therapeutics Investigative Site
  • Visus Therapeutics Investigative Site
  • Visus Therapeutics Investigative Site
  • Visus Therapeutics Investigative Site
  • Visus Therapeutics Investigative Site
  • Visus Therapeutics Investigative Site
  • Visus Therapeutics Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

BRIMOCHOL™ PF

Carbachol PF

Brimonidine tartrate

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 improvement in near VA without the loss of at least 1 line in distance VA

Secondary Outcome Measures

Full Information

First Posted
February 25, 2022
Last Updated
April 17, 2023
Sponsor
Visus Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT05270863
Brief Title
Safety and Efficacy Study BRIMOCHOL™ PF and Carbachol PF in Subjects With Emmetropic Phakic or Pseudophakic Presbyopia
Official Title
Multicenter, Double-Masked, Randomized, Safety and Efficacy Study of BRIMOCHOL™ PF and Carbachol PF Topical Ophthalmic Solution With Emmetropic Phakic and Pseudophakic Presbyopia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
March 30, 2022 (Actual)
Primary Completion Date
March 17, 2023 (Actual)
Study Completion Date
April 10, 2023 (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™ PF and Carbachol PF in Subjects With Emmetropic Phakic and Pseudophakic Presbyopia
Detailed Description
Multicenter, Double-Masked, Randomized, Safety and Efficacy Study of BRIMOCHOL™ PF and Carbachol PF Topical Ophthalmic Solution 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 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
182 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BRIMOCHOL™ PF
Arm Type
Experimental
Arm Description
A single drop in each eye at a visit.
Arm Title
Carbachol PF
Arm Type
Active Comparator
Arm Description
A single drop in each eye at a visit.
Arm Title
Brimonidine tartrate
Arm Type
Active Comparator
Arm Description
A single drop in each eye at a visit.
Intervention Type
Drug
Intervention Name(s)
BRIMOCHOL™ PF
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 PF
Other Intervention Name(s)
carbachol monotherapy
Intervention Description
A single drop in each eye at a visit.
Intervention Type
Drug
Intervention Name(s)
Brimonidine tartrate
Other Intervention Name(s)
brimonidine tartrate 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 improvement in near VA without the loss of at least 1 line in distance VA
Time Frame
Baseline Visit 1

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
Visus Therapeutics Investigative Site
City
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
Facility Name
Visus Therapeutics Investigative Site
City
Rancho Cordova
State/Province
California
ZIP/Postal Code
95670
Country
United States
Facility Name
Visus Therapeutics Investigative Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Visus Therapeutics Investigative Site
City
Morrow
State/Province
Georgia
ZIP/Postal Code
30260
Country
United States
Facility Name
Visus Therapeutics Investigative Site
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Visus Therapeutics Investigative Site
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66204
Country
United States
Facility Name
Visus Therapeutics Investigative Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64133
Country
United States
Facility Name
Visus Therapeutics Investigative Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64154
Country
United States
Facility Name
Visus Therapeutics Investigative Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
66762
Country
United States
Facility Name
Visus Therapeutics Investigative Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Visus Therapeutics Investigative Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
77027
Country
United States
Facility Name
Visus Therapeutics Investigative Site
City
Cedar Park
State/Province
Texas
ZIP/Postal Code
78613
Country
United States
Facility Name
Visus Therapeutics Investigative Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77027
Country
United States
Facility Name
Visus Therapeutics Investigative Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Visus Therapeutics Investigative Site
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Safety and Efficacy Study BRIMOCHOL™ PF and Carbachol PF in Subjects With Emmetropic Phakic or Pseudophakic Presbyopia

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