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

Sponsor
Visus Therapeutics (Other)
Overall Status
Completed
CT.gov ID
NCT04774237
Collaborator
(none)
81
3
3
6.9
27
3.9

Study Details

Study Description

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
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

Study Type:
Interventional
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 :
Mar 24, 2021
Actual Primary Completion Date :
Oct 19, 2021
Actual Study Completion Date :
Oct 19, 2021

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Change from baseline in near VA [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 [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

    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 Global Research Management, Inc. Glendale California United States 91204
    2 Eye Research Foundation Newport Beach California United States 92663
    3 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:
    NCT04774237
    Other Study ID Numbers:
    • VT-001
    First Posted:
    Mar 1, 2021
    Last Update Posted:
    Nov 8, 2021
    Last Verified:
    Nov 1, 2021
    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 Nov 8, 2021