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

October 13, 2022 updated by: Visus Therapeutics

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

Safety and Efficacy Study of BRIMOCHOL™ vs. BRIMOCHOL™ F vs. Carbachol Monotherapy Topical Ophthalmic Solutions in Subjects with Emmetropic Phakic and Pseudophakic Presbyopia

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Glendale, California, United States, 91204
        • Global Research Management, Inc.
      • Newport Beach, California, United States, 92663
        • Eye Research Foundation
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Total Eye Care, PA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

43 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BRIMOCHOL™
A single drop in each eye at a visit.
Drug: BRIMOCHOL™
A single drop in each eye at a visit.
Other Names:
  • carbachol/brimonidine tartrate
Experimental: BRIMOCHOL™ F
A single drop in each eye at a visit.
Drug: BRIMOCHOL™ F
A single drop in each eye at a visit.
Other Names:
  • carbachol/brimonidine tartrate
Active Comparator: Carbachol
A single drop in each eye at a visit.
Drug: Carbachol
A single drop in each eye at a visit.
Other Names:
  • carbachol monotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in near VA
Time Frame: Baseline
Percentage of subjects with 3-line gains in near VA at various time points
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in distance VA
Time Frame: From baseline through hour 9 at each study visit
Percentage of subjects with 1-line loss in distance VA at various time points
From baseline through hour 9 at each study visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Visus Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 24, 2021

Primary Completion (Actual)

October 19, 2021

Study Completion (Actual)

October 19, 2021

Study Registration Dates

First Submitted

February 23, 2021

First Submitted That Met QC Criteria

February 25, 2021

First Posted (Actual)

March 1, 2021

Study Record Updates

Last Update Posted (Actual)

October 17, 2022

Last Update Submitted That Met QC Criteria

October 13, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VT-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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