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A Phase II Trial of G01 Eye Drops for Glaucomatous Optic Neuropathy
Sponsor: Qingdao WanMing BioCell Pharmaceutics Co.,Ltd.
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2026-03-18
Completion Date
2027-12-01
Last Updated
2026-08-20
Healthy Volunteers
No
Interventions
G01 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.
G01 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.
Placebo 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.
Locations (9)
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Peking University First Hospital
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, China
Joint Shantou International Eye Center of Shantou University and The Chinese University of Hong Kong
Shantou, Guangdong, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
Tianjin Eye Hospital
Tianjin, Tianjin Municipality, China
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Eye Hospital, Wenzhou Medical University
Wenzhou, Zhejiang, China