NCT04774237

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Visus Therapeutics · Academic / Other
• Sex: All
• Age: 45 Years – 80 Years
• Healthy volunteers: Accepted

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

Conditions

• Presbyopia

Interventions

Type	Name	Description
DRUG	BRIMOCHOL™	A single drop in each eye at a visit.
DRUG	BRIMOCHOL™ F	A single drop in each eye at a visit.
DRUG	Carbachol	A single drop in each eye at a visit.

Timeline

• Start date: 2021-03-24
• Primary completion: 2021-10-19
• Completion: 2021-10-19
• First posted: 2021-03-01
• Last updated: 2026-03-27
• Results posted: 2025-02-05

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study