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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

Tracking Information
First Submitted Date  ICMJE February 23, 2021
First Posted Date  ICMJE March 1, 2021
Last Update Posted Date October 17, 2022
Actual Study Start Date  ICMJE March 24, 2021
Actual Primary Completion Date October 19, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2021)		 Change from baseline in near VA [ Time Frame: Baseline ]
Percentage of subjects with 3-line gains in near VA at various time points
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 25, 2021)		 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
Original Secondary Outcome Measures  ICMJE
 (submitted: February 25, 2021)		 Change from baseline in distance VA [ Time Frame: From baseline through HR 9 at each study visit ]
Percentage of subjects with 1-line loss in distance VA at various time points
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of BRIMOCHOL™, BRIMOCHOL™ F, and Carbachol in Subjects With Emmetropic Phakic and Pseudophakic Presbyopia
Official Title  ICMJE 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
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
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Presbyopia
Intervention  ICMJE
  • Drug: BRIMOCHOL™
    A single drop in each eye at a visit.
    Other Name: carbachol/brimonidine tartrate
  • Drug: BRIMOCHOL™ F
    A single drop in each eye at a visit.
    Other Name: carbachol/brimonidine tartrate
  • Drug: Carbachol
    A single drop in each eye at a visit.
    Other Name: carbachol monotherapy
Study Arms  ICMJE
  • Experimental: BRIMOCHOL™
    A single drop in each eye at a visit.
    Intervention: Drug: BRIMOCHOL™
  • Experimental: BRIMOCHOL™ F
    A single drop in each eye at a visit.
    Intervention: Drug: BRIMOCHOL™ F
  • Active Comparator: Carbachol
    A single drop in each eye at a visit.
    Intervention: Drug: Carbachol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 5, 2021)		 81
Original Estimated Enrollment  ICMJE
 (submitted: February 25, 2021)		 40
Actual Study Completion Date  ICMJE October 19, 2021
Actual Primary Completion Date October 19, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04774237
Other Study ID Numbers  ICMJE VT-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Visus Therapeutics
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Visus Therapeutics
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Visus Therapeutics
Verification Date October 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP