A Phase II Trial of G01 Eye Drops for Glaucomatous Optic Neuropathy
Sponsor: Qingdao WanMing BioCell Pharmaceutics Co.,Ltd. • ClinicalTrials.gov ID: NCT07777861
Recruiting for Similar Conditions?
Sponsors are looking for patients like you. See if you qualify for compensated research studies.
Check Eligibility →Description
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.
Interventions
-
G01 Eye Drops 100μg/ml
(Drug)
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
(Drug)
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
(Drug)
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.
Eligibility criteria
Conditions
Locations
- 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
Partner with Nurenyx
Showcase your study to thousands of motivated patients matching your criteria.
Learn MoreOfficial Source
Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
View Official Record