A Randomized, Double-Masked, Placebo-Controlled Phase II Clinical Trial Evaluating the Efficacy and Safety of G01 Eye Drops in the Treatment of Optic Nerve Injury Associated With Open-Angle Glaucoma
This is a randomized, double-masked, placebo-controlled Phase II clinical trial. The primary objective is to explore the efficacy of G01 Eye Drops in the treatment of optic nerve injury associated with open-angle glaucoma, providing supportive evidence for the design of subsequent clinical trials. The secondary objectives are to evaluate the safety, pharmacokinetic profiles, and immunogenicity of G01 Eye Drops in the target patient population.
• Age from 18 to 80 years (inclusive) at the time of signing the informed consent form, regardless of gender.
• Diagnosis of primary open-angle glaucoma (POAG) in one or both eyes.
• Goal eye demonstrates disease progression as shown by Guided Progression Analysis (GPA) visual field testing at screening.
• Mean Deviation (MD) of the visual field in the goal eye ≥-16 dB and ≤-3 dB.
• Best-corrected visual acuity of the goal eye ≥0.3; spherical equivalent refraction ≥-8 D (spherical equivalent = spherical refraction + 1/2 cylindrical refraction) OR axial length ≤28 mm in the goal eye.
• Intraocular pressure of the goal eye ranges from 10 mmHg to 21 mmHg (inclusive) under hypotensive medication, post-glaucoma surgery, or no medication; and the intraocular pressure is judged stably controlled by the investigator.
• Subjects and their partners agree to use effective physical and/or pharmacological contraception from screening through 3 months after study completion; no plan for sperm/egg donation or pregnancy.
• Voluntarily sign the informed consent form for participation in this clinical trial and comply with investigator-provided instructions.