Grove

Researchers are evaluating the safety, tolerability, and effectiveness of GRF312 5% ophthalmic solution in adults with Dry Eye Disease (DED) through a Phase 2, multi-site, double-blind, randomized, vehicle-controlled study. The study focuses on adults who have a history of DED and meet specific clinical criteria for moderate to severe disease. This research aims to compare GRF312 5% to a placebo vehicle to better understand its potential benefits and risks for those affected by DED. Participants will be randomly assigned to receive either the GRF312 5% eye drops or a placebo vehicle. They will self-administer these eye drops according to the study instructions throughout the treatment period. The study includes a screening phase, a run-in period, and a treatment phase lasting up to 84 days. During this time, participants will be closely monitored for any treatment-emergent adverse events, serious adverse events, and any events that may cause them to stop treatment. Throughout the study, participants will attend required visits where their visual acuity, symptom severity, and other eye health measures will be assessed. Researchers will track safety and tolerability, as well as how participants respond to the treatment. The main outcomes include the number and proportion of participants experiencing adverse events up to Day 84. Participants will need to follow the study protocol carefully and attend all scheduled visits for the duration of the trial.