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

NCT07777861 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-08-24

No results posted yet for this study

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.

Conditions

  • Primary Open-Angle Glaucoma
  • Optic Nerve Injury

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.

Sponsors & Collaborators

  • Qingdao WanMing BioCell Pharmaceutics Co.,Ltd.

    lead INDUSTRY

Principal Investigators

  • Yuanbo Liang · Eye Hospital, Wenzhou Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-18
Primary Completion
2027-10-01
Completion
2027-12-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07777861 on ClinicalTrials.gov