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

Presbyopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04774237
• Other study ID #: VT-001
• Status: Completed
• Phase: Phase 2
• Start date: March 24, 2021
• Est. completion date: October 19, 2021

Study information

• Verified date: October 2022
• Source: Visus Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: October 19, 2021
• Est. primary completion date: October 19, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Presbyopia

Intervention

Drug:
• BRIMOCHOL™
A single drop in each eye at a visit.
• BRIMOCHOL™ F
A single drop in each eye at a visit.
• Carbachol
A single drop in each eye at a visit.

Locations

Country	Name	City	State
United States	Global Research Management, Inc.	Glendale	California
United States	Total Eye Care, PA	Memphis	Tennessee
United States	Eye Research Foundation	Newport Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
Visus Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in near VA	Percentage of subjects with 3-line gains in near VA at various time points	Baseline
Secondary	Change from baseline in distance VA	Percentage of subjects with 1-line loss in distance VA at various time points	From baseline through hour 9 at each study visit