Phase 3 N=182 Randomized Double-blind Treatment

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

Presbyopia

Bottom Line

View on ClinicalTrials.gov: NCT05270863 ↗

Enrolled (actual)

182

Serious AEs

0.2%

Results posted

Sep 2024

Primary outcome: Primary: Proportion of Subjects With >=15 Letter Gain Without >=5 Letter Loss in Near Visual Acuity — 49.4; 35.0; 22.7 Percentage of participants — p=<.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: BRIMOCHOL™ PF (Drug); Carbachol PF (Drug); Brimonidine tartrate (Drug)
Age: Adult, Older Adult · 45+ yrs
Sex: All
Sponsor: Visus Therapeutics
Primary completion: Mar 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Proportion of Subjects With >=15 Letter Gain Without >=5 Letter Loss in Near Visual Acuity	49.4; 35.0; 22.7	<.001 sig

Summary

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

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05270863). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.