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

Visus Therapeutics18 enrolled

Overview

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

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Presbyopia

Interventions

BRIMOCHOL™DRUG

A single drop in each eye at a visit.

BRIMOCHOL™ FDRUG

A single drop in each eye at a visit.

CarbacholDRUG

A single drop in each eye at a visit.

Eligibility

Sex: ALLMin age: 45 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (3)

Global Research Management, Inc.

Glendale, California, United States

Eye Research Foundation

Newport Beach, California, United States

Total Eye Care, PA

Memphis, Tennessee, United States

Outcomes

Primary Outcomes

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

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

Time frame: Day 1, Hour 1 post-dose

Secondary Outcomes

Change From Baseline ETDRS Letters Score in Distance Visual Acuity

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

Time frame: Day 1, Hour 1 post-dose

Data from ClinicalTrials.gov

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