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RECRUITING
NCT07777861
PHASE2

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

Sponsor: Qingdao WanMing BioCell Pharmaceutics Co.,Ltd.

View on ClinicalTrials.gov

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

DRUG

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.

DRUG

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.

DRUG

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