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.

Imagine being able to read a menu or a text message without fumbling for your reading glasses. That's the hope for people with presbyopia, the age-related condition that makes close-up vision blurry. A small, completed study tested three different eye drop formulas—BRIMOCHOL™, BRIMOCHOL™ F, and carbachol—to see if they could help. The study involved 18 people who either had their natural lens or an artificial lens implant. The main goal was to see how many people could gain a significant improvement in their near vision (reading letters up close) without losing any meaningful distance vision. The study was designed as a crossover trial, meaning each person tried the different drops in a random order, and neither the participants nor the doctors knew which drop was being used at any time. This type of design helps get a clearer picture of how the treatments compare. The abstract confirms the study is finished, but it does not share the specific findings on how safe the drops were or how well they worked compared to each other. The results were posted in early 2025.