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

Phase 2

Completed

• Conditions: Presbyopia
• Interventions: Drug: BRIMOCHOL™ F; Drug: BRIMOCHOL™; Drug: Carbachol

• Registration Number: NCT04774237
• Lead Sponsor: Visus Therapeutics

Brief Summary

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

Detailed 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

Study Timeline

• Study First Submitted: 2021-02-23
• Study First Submitted QC: 2021-02-25
• Study First Posted: 2021-03-01
• Study Start: 2021-03-24
• Primary Completion: 2021-10-19
• Study Completion: 2021-10-19
• Disposition First Submitted: 2022-10-10
• Results First Submitted: 2024-10-10
• Status Verified: 2025-02
• Results First Submitted QC: 2025-02-03
• Last Update Submitted: 2025-02-03
• Results First Posted: 2025-02-05
• Disposition First Posted: 2025-02-05
• Last Update Posted: 2025-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Proportion of Subjects With a >=15 Letter Gain Without a < 5 Letter Loss in Near Visual Acuity	Day 1, Hour 1 post-dose	Primary Endpoint measured at Hour 1 post-dose at Study Visit - a Single drop Cohort

Secondary Outcome Measures

Name	Time	Method
Change From Baseline ETDRS Letters Score in Distance Visual Acuity	Day 1, Hour 1 post-dose	Secondary Endpoint measured at Hour 1 post-dose at Study Visit - a Single drop Cohort

Trial Locations

Locations (3)

Total Eye Care, PA; 🇺🇸 Memphis, Tennessee, United States

Global Research Management, Inc.; 🇺🇸 Glendale, California, United States

Eye Research Foundation; 🇺🇸 Newport Beach, California, United States