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

Sponsor
Visus Therapeutics (Other)
Overall Status
Recruiting
CT.gov ID
NCT05135286
Collaborator
(none)
450
1
3
14.5
31

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
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 :
450 participants
Allocation:
Randomized
Intervention Model:
Parallel 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 15, 2022
Anticipated Primary Completion Date :
Mar 31, 2023
Anticipated Study Completion Date :
May 31, 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
  • Placebo Comparator: Vehicle

    A single drop in each eye at a visit.

    Drug: Vehicle
    A single drop in each eye at a visit.

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline in near VA [Baseline Day 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 Nature Coast Clinical Research Crystal River Florida United States 34429

    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:
    NCT05135286
    Other Study ID Numbers:
    • VT-003
    First Posted:
    Nov 26, 2021
    Last Update Posted:
    Apr 26, 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:

    Study Results

    No Results Posted as of Apr 26, 2022