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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04774237
Recruitment Status : Completed
First Posted : March 1, 2021
Last Update Posted : October 17, 2022
Sponsor:
Information provided by (Responsible Party):
Visus Therapeutics

Study Description
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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

Condition or disease Intervention/treatment Phase
Presbyopia Drug: BRIMOCHOL™ Drug: BRIMOCHOL™ F Drug: Carbachol Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : March 24, 2021
Actual Primary Completion Date : October 19, 2021
Actual Study Completion Date : October 19, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Carbachol

Arms and Interventions
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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 Name: 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 Name: 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 Name: carbachol monotherapy


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in near VA [ Time Frame: Baseline ]
    Percentage of subjects with 3-line gains in near VA at various time points


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04774237


Locations
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United States, California
Global Research Management, Inc.
Glendale, California, United States, 91204
Eye Research Foundation
Newport Beach, California, United States, 92663
United States, Tennessee
Total Eye Care, PA
Memphis, Tennessee, United States, 38119
Sponsors and Collaborators
Visus Therapeutics
More Information
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Responsible Party: Visus Therapeutics
ClinicalTrials.gov Identifier: NCT04774237    
Other Study ID Numbers: VT-001
First Posted: March 1, 2021    Key Record Dates
Last Update Posted: October 17, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Presbyopia
Refractive Errors
Eye Diseases
Brimonidine Tartrate
Carbachol
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
 Physiological Effects of Drugs
Cardiotonic Agents
Miotics
Autonomic Agents
Peripheral Nervous System Agents
Cholinergic Agonists
Cholinergic Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Protective Agents