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

Visus Therapeutics

Status and phase: Completed; Phase 2

Conditions: Presbyopia

Treatments: Drug: BRIMOCHOL™; Drug: BRIMOCHOL™ F; Drug: Carbachol

Study type: Interventional

Funder types: Other

Identifiers

NCT04774237

VT-001

Details and patient eligibility

About

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

Full 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

Enrollment: 18 patients

Sex: All

Ages: 45 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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18 participants in 3 patient groups

BRIMOCHOL™

Experimental group

Description:

A single drop in each eye at a visit.

Treatment:

Drug: BRIMOCHOL™

BRIMOCHOL™ F

Experimental group

Description:

A single drop in each eye at a visit.

Treatment:

Drug: BRIMOCHOL™ F

Carbachol

Active Comparator group

Description:

A single drop in each eye at a visit.

Treatment:

Drug: Carbachol