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

Primary Purpose

Presbyopia

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
BRIMOCHOL™ PF
Carbachol PF
Vehicle
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 SiteRecruiting
  • Visus Therapeutics Investigative SiteRecruiting
  • Visus Therapeutics Investigative SiteRecruiting
  • Visus Therapeutics Investigative SiteRecruiting
  • Visus Therapeutics Investigative SiteRecruiting
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  • Visus Therapeutics Investigative Site
  • Visus Therapeutics Investigative SiteRecruiting
  • Visus Therapeutics Investigative SiteRecruiting
  • Visus Therapeutics Investigative SiteRecruiting
  • Visus Therapeutics Investigative SiteRecruiting
  • Visus Therapeutics Investigative SiteRecruiting
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  • Visus Therapeutics Investigative SiteRecruiting
  • Visus Therapeutics Investigative SiteRecruiting
  • Visus Therapeutics Investigative SiteRecruiting
  • Visus Therapeutics Investigative SiteRecruiting
  • Visus Therapeutics Investigative SiteRecruiting
  • Visus Therapeutics Investigative SiteRecruiting
  • Visus Therapeutics Investigative SiteRecruiting
  • Visus Therapeutics Investigative SiteRecruiting
  • Visus Therapeutics Investigative SiteRecruiting
  • Visus Therapeutics Investigative SiteRecruiting
  • Visus Therapeutics Investigative SiteRecruiting
  • Visus Therapeutics Investigative SiteRecruiting
  • Visus Therapeutics Investigative SiteRecruiting
  • Visus Therapeutics Investigative SiteRecruiting
  • Visus Therapeutics Investigative SiteRecruiting
  • Visus Therapeutics Investigative SiteRecruiting
  • Visus Therapeutics Investigative SiteRecruiting
  • Visus Therapeutics Investigative SiteRecruiting
  • Visus Therapeutics Investigative SiteRecruiting
  • Visus Therapeutics Investigative SiteRecruiting
  • Visus Therapeutics Investigative SiteRecruiting
  • Visus Therapeutics Investigative SiteRecruiting
  • Visus Therapeutics Investigative SiteRecruiting
  • Visus Therapeutics Investigative SiteRecruiting
  • Visus Therapeutics Investigative SiteRecruiting
  • Visus Therapeutics Investigative SiteRecruiting
  • Visus Therapeutics Investigative SiteRecruiting
  • Visus Therapeutics Investigative SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

BRIMOCHOL™ PF

Carbachol PF

Vehicle

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
November 4, 2021
Last Updated
September 30, 2022
Sponsor
Visus Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT05135286
Brief Title
Safety and Efficacy Study of BRIMOCHOL™ PF and Carbachol PF in Subjects With Emmetropic Phakic and 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
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2022 (Actual)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
May 31, 2023 (Anticipated)

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
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
450 (Anticipated)

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
Vehicle
Arm Type
Placebo 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)
Vehicle
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 Day 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Le
Phone
(800) 281-4536
Email
david.le@visustx.com
Facility Information:
Facility Name
Visus Therapeutics Investigative Site
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
M. Farooqi
Phone
480-999-5458
Facility Name
Visus Therapeutics Investigative Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
A. Buschman
Phone
480-999-5458
Facility Name
Visus Therapeutics Investigative Site
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
A. Buschman
Phone
480-999-5458
Facility Name
Visus Therapeutics Investigative Site
City
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
O. Karram
Phone
818-246-2560
Facility Name
Visus Therapeutics Investigative Site
City
Inglewood
State/Province
California
ZIP/Postal Code
90301
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
C. Caballero-Marin
Phone
310-641-4673
Facility Name
Visus Therapeutics Investigative Site
City
Irvine
State/Province
California
ZIP/Postal Code
92604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
L. Zavalza
Phone
949-733-2022
Facility Name
Visus Therapeutics Investigative Site
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
K. Taylor
Phone
661-609-2475
Facility Name
Visus Therapeutics Investigative Site
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
R. Castillo
Phone
949-427-6099
Facility Name
Visus Therapeutics Investigative Site
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Visus Therapeutics Investigative Site
City
Pasadena
State/Province
California
ZIP/Postal Code
91107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
S. Wade
Phone
626-793-4168
Facility Name
Visus Therapeutics Investigative Site
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
K. Rosenbusch
Phone
480-999-5458
Facility Name
Visus Therapeutics Investigative Site
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sh. Patel
Phone
720-709-7533
Facility Name
Visus Therapeutics Investigative Site
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
A. Smit
Phone
203-791-2020
Facility Name
Visus Therapeutics Investigative Site
City
Crystal River
State/Province
Florida
ZIP/Postal Code
34429
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
N. Smith
Phone
352-563-1865
Facility Name
Visus Therapeutics Investigative Site
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Y. King
Phone
561-315-5219
Facility Name
Visus Therapeutics Investigative Site
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33309
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
V. Jean-Baptiste
Phone
954-597-6445
Facility Name
Visus Therapeutics Investigative Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
J. Montgomery
Phone
904-296-0098
Facility Name
Visus Therapeutics Investigative Site
City
Largo
State/Province
Florida
ZIP/Postal Code
33770
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
R. Bondurant
Phone
727-450-4668
Facility Name
Visus Therapeutics Investigative Site
City
Mount Dora
State/Province
Florida
ZIP/Postal Code
32757
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
N. Woodall
Phone
352-989-0932
Facility Name
Visus Therapeutics Investigative Site
City
Lake Villa
State/Province
Illinois
ZIP/Postal Code
60046
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
A. Wojtysiak
Phone
847-445-5491
Facility Name
Visus Therapeutics Investigative Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
M. Price
Phone
317-844-5530
Facility Name
Visus Therapeutics Investigative Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40206
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
J. Powell-Sutton
Phone
502-589-1500
Facility Name
Visus Therapeutics Investigative Site
City
Bloomington
State/Province
Minnesota
ZIP/Postal Code
55420
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
N. Jacobs
Phone
612-770-6808
Facility Name
Visus Therapeutics Investigative Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
M. Hefter
Phone
816-531-9100
Facility Name
Visus Therapeutics Investigative Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
K. Tincknell
Phone
314-842-2020
Facility Name
Visus Therapeutics Investigative Site
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
P. Bouddhabandith
Phone
480-999-5458
Facility Name
Visus Therapeutics Investigative Site
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12603
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
C. Sportiello
Phone
845-454-1025
Facility Name
Visus Therapeutics Investigative Site
City
Garner
State/Province
North Carolina
ZIP/Postal Code
27529
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
J. Newsome
Phone
252-904-5415
Facility Name
Visus Therapeutics Investigative Site
City
W. Fargo
State/Province
North Dakota
ZIP/Postal Code
58078
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
A. Saville
Phone
701-809-9905
Facility Name
Visus Therapeutics Investigative Site
City
Powell
State/Province
Ohio
ZIP/Postal Code
43065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
J. Smith
Phone
614-793-0700
Facility Name
Visus Therapeutics Investigative Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
J. Rees
Phone
503-413-8202
Facility Name
Visus Therapeutics Investigative Site
City
Cranberry Township
State/Province
Pennsylvania
ZIP/Postal Code
16066
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
N. Hindman
Phone
724-772-3000
Facility Name
Visus Therapeutics Investigative Site
City
Wilkes-Barre
State/Province
Pennsylvania
ZIP/Postal Code
18702
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
B. Michalek
Phone
570-270-5281
Facility Name
Visus Therapeutics Investigative Site
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
K. Dunne
Phone
605-361-3937
Facility Name
Visus Therapeutics Investigative Site
City
Maryville
State/Province
Tennessee
ZIP/Postal Code
37803
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
K. Rivera
Phone
865-671-1234
Facility Name
Visus Therapeutics Investigative Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
D. Ashe
Phone
901-761-4620
Facility Name
Visus Therapeutics Investigative Site
City
Smyrna
State/Province
Tennessee
ZIP/Postal Code
37167
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
M. Medlin
Phone
615-502-2871
Facility Name
Visus Therapeutics Investigative Site
City
Hurst
State/Province
Texas
ZIP/Postal Code
76054
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
B. Bott
Phone
817-540-6060
Facility Name
Visus Therapeutics Investigative Site
City
Lakeway
State/Province
Texas
ZIP/Postal Code
78738
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
S. Boldt
Phone
512-721-8352
Facility Name
Visus Therapeutics Investigative Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
C. Hazen
Phone
210-424-2584
Facility Name
Visus Therapeutics Investigative Site
City
Draper
State/Province
Utah
ZIP/Postal Code
84020
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
M. Avila, MD
Phone
801-988-7346
Facility Name
Visus Therapeutics Investigative Site
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22046
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
K. Ng
Phone
202-239-0777
Facility Name
Visus Therapeutics Investigative Site
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24502
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
C. Torrence
Phone
434-947-3984

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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