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

Visus Therapeutics

Status and phase: Completed; Phase 3

Conditions: Presbyopia

Treatments: Drug: Vehicle; Drug: BRIMOCHOL™ PF; Drug: Carbachol PF

Study type: Interventional

Funder types: Other

Identifiers

NCT05135286

VT-003

Details and patient eligibility

About

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

Full description

Multicenter, Double-Masked, Randomized, Safety and Efficacy Study of BRIMOCHOL™ PF and Carbachol PF Topical Ophthalmic Solution With Emmetropic Phakic and Pseudophakic Presbyopia

Enrollment: 629 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: Parallel Assignment

Masking: Double Blind

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629 participants in 3 patient groups, including a placebo group

BRIMOCHOL™ PF

Experimental group

Description:

A single drop in each eye at a visit.

Treatment:

Drug: BRIMOCHOL™ PF

Carbachol PF

Active Comparator group

Description:

A single drop in each eye at a visit.

Treatment:

Drug: Carbachol PF

Vehicle

Placebo Comparator group

Description:

A single drop in each eye at a visit.

Treatment:

Drug: Vehicle