Phase 2 trial of BRIMOCHOL, BRIMOCHOL F, and carbachol for presbyopia completes with 18 subjects

A Phase 2, multicenter, randomized, double-masked, crossover study was conducted to evaluate the safety and efficacy of three topical ophthalmic solutions: BRIMOCHOL™, BRIMOCHOL™ F, and carbachol monotherapy. The study enrolled 18 subjects diagnosed with emmetropic phakic and pseudophakic presbyopia. The trial design involved a three-dose comparison in a crossover format. The primary efficacy endpoint was the proportion of subjects achieving a gain of 15 or more letters in near visual acuity without experiencing a loss of 5 or more letters. The study was initiated on March 24, 2021, and reached primary completion on October 19, 2021. The results from this study were posted on February 5, 2025. The abstract provides the study's status, phase, design, population, interventions, primary outcome measure, enrollment number, sponsor, and key dates. Specific numerical results for the primary or secondary outcomes, including the proportion of subjects meeting the primary endpoint, p-values, confidence intervals, or detailed safety data, are not reported in the provided abstract text.