A Phase II Trial of G01 Eye Drops for Glaucomatous Optic Neuropathy

Eligible patients with open-angle glaucoma and concomitant optic nerve injury will be randomized to receive either topical G01 Eye Drops or matched placebo. Multiple assessments of efficacy, safety, pharmacokinetics (PK), and immunogenicity are conducted at predefined time points following the first administration of the study drug. The primary efficacy endpoint is the change from baseline in visual field mean deviation (MD) at Day 168. Secondary efficacy endpoints include changes from baseline in visual field MD at Days 28, 84, 252, and 336, as well as changes from baseline in retinal nerve fiber layer (RNFL) thickness, macular ganglion cell-inner plexiform layer (GCIPL) thickness, and P100 wave amplitude and latency of pattern visual evoked potential (PVEP) at Days 28, 84, 168, 252, and 336. Additional secondary endpoints encompass pharmacokinetic characterization through plasma and tear drug concentration measurements, evaluation of anti-drug antibody (ADA) positive rates and neutralizing antibody levels, and comprehensive safety assessments throughout the study, including adverse events, vital signs, physical examinations, laboratory tests, and ophthalmic evaluations. All participants will complete the scheduled assessments according to the protocol to systematically evaluate the overall clinical profile of G01 Eye Drops.