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

Phase 3

Active, not recruiting

• Conditions: Presbyopia
• Interventions: Drug: BRIMOCHOL™ PF; Drug: Vehicle; Drug: Carbachol PF

• Registration Number: NCT05135286
• Lead Sponsor: Visus Therapeutics

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2021-11-04
• Study First Submitted QC: 2021-11-19
• Study First Posted: 2021-11-26
• Study Start: 2022-03-15
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-22
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 450

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BRIMOCHOL™ PF	BRIMOCHOL™ PF	A single drop in each eye at a visit.
Vehicle	Vehicle	A single drop in each eye at a visit.
Carbachol PF	Carbachol PF	A single drop in each eye at a visit.

Primary Outcome Measures

Name	Time	Method
Change from baseline in near VA	Baseline Day 1	Percentage of subjects with 3-line improvement in near VA without the loss of at least 1 line in distance VA

Trial Locations

Locations (1)

Visus Therapeutics Investigative Site; 🇺🇸 Lynchburg, Virginia, United States