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

Sponsor
Visus Therapeutics (Other)
Overall Status
Recruiting
CT.gov ID
NCT05270863
Collaborator
(none)
170
Enrollment
1
Location
3
Arms
9.2
Anticipated Duration (Months)
18.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: BRIMOCHOL™ PF
  • Drug: Carbachol PF
  • Drug: Brimonidine tartrate
 Phase 3

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
170 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Mar 30, 2022
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Jan 5, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: BRIMOCHOL™ PF

A single drop in each eye at a visit.

Drug: BRIMOCHOL™ PF
A single drop in each eye at a visit.
Other Names:
  • carbachol/brimonidine tartrate

    		•
    Active Comparator: Carbachol PF

    A single drop in each eye at a visit.

    Drug: Carbachol PF
    A single drop in each eye at a visit.
    Other Names:
  • carbachol monotherapy

    		•
    Active Comparator: Brimonidine tartrate

    A single drop in each eye at a visit.

    Drug: Brimonidine tartrate
    A single drop in each eye at a visit.
    Other Names:
  • brimonidine tartrate monotherapy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline in near VA [Baseline Visit 1]

      Percentage of subjects with 3-line improvement in near VA without the loss of at least 1 line in distance VA

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 Total Eye Care, PA Memphis Tennessee United States 38119

    Sponsors and Collaborators

    • Visus Therapeutics

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Visus Therapeutics
    ClinicalTrials.gov Identifier:
    NCT05270863
    Other Study ID Numbers:
    • VT-002
    First Posted:
    Mar 8, 2022
    Last Update Posted:
    May 2, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Presbyopia
    Brimonidine Tartrate
    Carbachol

    Study Results

    No Results Posted as of May 2, 2022