Safety and Efficacy Study BRIMOCHOL™ PF and Carbachol PF in Subjects With Emmetropic Phakic or Pseudophakic Presbyopia
Phase 3
Completed
- Conditions
- Presbyopia
- Interventions
- Registration Number
- NCT05270863
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 182
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 Carbachol PF Carbachol PF A single drop in each eye at a visit. BRIMOCHOL™ PF BRIMOCHOL™ PF A single drop in each eye at a visit. Brimonidine tartrate Brimonidine tartrate A single drop in each eye at a visit.
- Primary Outcome Measures
Name Time Method Proportion of Subjects With >=15 Letter Gain Without >=5 Letter Loss in Near Visual Acuity Day 1 Hour 1 Primary endpoint measure at hour 1 post-dose at study visit
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Visus Therapeutics Investigative Site
🇺🇸Ogden, Utah, United States