drugset / Trial / NCT05270863

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

NCT05270863 ↗

Phase 3 Completed 182 enrolled Visus Therapeutics
RandomizedCrossoverDouble-blindTreatment

Summary

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

Timeline

Start
2022-03-30
Primary completion
2023-03-17
Completion
2023-04-10

Outcome

Met primary endpoint

registry NUMBER BRIMOCHOL™ PF: 49.4 (41.9 to 57.0) Percentage of participants NCT05270863 ↗

registry analysis (superiority test); BRIMOCHOL™ PF vs Carbachol PF vs Brimonidine Tartrate; p <.001; Regression, Logistic NCT05270863 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject BRIMOCHOL Unknown — Topical
Comparator Brimonidine Unknown — Other
Comparator CARBAMOYLCHOLINE Small molecule — Topical

Indications