RecruitingPhase 2NCT07777861

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

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

Sponsor

Qingdao WanMing BioCell Pharmaceutics Co.,Ltd.

Enrollment

90 participants

Start Date

Mar 18, 2026

Study Type

INTERVENTIONAL

Conditions

Primary Open Angle Glaucoma Optic Nerve Injury

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called G01 Eye Drops 100μg/ml, a drug called G01 Eye Drops 200μg/ml, and others for people with optic nerve injury and primary open angle glaucoma. The study is currently recruiting participants at 9 locations. People eligible for this study include aged 18 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGG01 Eye Drops 100μg/ml

Investigational G01 Eye Drops (100 μg/mL), administered topically to the eye, twice daily, one drop (approximately 33 μL) per dose, for a 24-week treatment period, for patients with optic nerve injury associated with primary open-angle glaucoma.

DRUGG01 Eye Drops 200μg/ml

Investigational G01 Eye Drops (200 μg/mL), administered topically to the eye, twice daily, one drop (approximately 33 μL) per dose, for a 24-week treatment period, for patients with optic nerve injury associated with primary open-angle glaucoma.

DRUGPlacebo of G01 Eye Drops

Matched placebo eye drops, identical in appearance, viscosity and packaging to G01 Eye Drops. Administered topically to the eye, twice daily, one drop (approximately 33 μL) per dose for a 24-week treatment period to maintain study blinding.