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OpenTrials
Completed

NCT Number: NCT04774237

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

Safety and Efficacy Study of BRIMOCHOL™ vs. BRIMOCHOL™ F vs. Carbachol Monotherapy Topical Ophthalmic Solutions in Subjects with Emmetropic Phakic and Pseudophakic Presbyopia

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Key information

Conditions

Presbyopia Eye Diseases Refractive Errors

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Global Research Management, Inc., Glendale, California, United States

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BRIMOCHOL™

Drug

A single drop in each eye at a visit.

Other names: carbachol/brimonidine tartrate

BRIMOCHOL™ F

Drug

A single drop in each eye at a visit.

Other names: carbachol/brimonidine tartrate

Carbachol

Drug

A single drop in each eye at a visit.

Other names: carbachol monotherapy

Primary outcomes

  1. Proportion of Subjects With a >=15 Letter Gain Without a < 5 Letter Loss in Near Visual Acuity

    Time frame: Day 1, Hour 1 post-dose

    Primary Endpoint measured at Hour 1 post-dose at Study Visit - a Single drop Cohort

Secondary outcomes

  1. Change From Baseline ETDRS Letters Score in Distance Visual Acuity

    Time frame: Day 1, Hour 1 post-dose

    Secondary Endpoint measured at Hour 1 post-dose at Study Visit - a Single drop Cohort

Sponsors and collaborators

Lead sponsor

Visus Therapeutics

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 1, 2021
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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