Can a simple eye drop protect the optic nerve in glaucoma?
NCT ID NCT07777861
First seen Aug 20, 2026 · Last updated Aug 25, 2026 · Updated 3 times
Summary
This phase II trial is testing whether an investigational eye drop called G01 can protect the optic nerve and slow vision loss in people with primary open-angle glaucoma. The study includes 90 adults with glaucoma who show signs of disease progression. Participants will receive either G01 or a placebo, applied twice daily for 24 weeks, and researchers will measure changes in visual field and nerve thickness to see if the treatment helps.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- G01 eye drops (an investigational drug)
- What this could lead to
- If successful, this could lead to a new eye drop treatment that slows optic nerve damage and helps preserve vision in people with glaucoma.
- What could go wrong
- This is an early-stage trial with a small number of participants, so the treatment may not prove effective or safe. Possible risks include eye irritation or other side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age from 18 to 80 years (inclusive) at the time of signing the informed consent form, regardless of gender. * Diagnosis of primary open-angle glaucoma (POAG) in one or both eyes. * Goal eye demonstrates disease progression as shown by Guided Progression Analysis (GPA) visual field testing at screening. * Mean Deviation (MD) of the visual field in the goal eye ≥-16 dB and ≤-3 dB. * Best-corrected visual acuity of the goal eye ≥0.3; spherical equivalent refraction ≥-8 D (spherical equivalent = spherical refraction + 1/2 cylindrical refraction) OR axial length ≤28 mm in the goal eye. * Intraocular pressure of the goal eye ranges from 10 mmHg to 21 mmHg (inclusive) under hypotensive medication, post-glaucoma surgery, or no medication; and the intraocular pressure is judged stably controlled by the investigator. * Subjects and their partners agree to use effective physical and/or pharmacological contraception from screening through 3 months after study completion; no plan for sperm/egg donation or pregnancy. * Voluntarily sign the informed consent form for participation in this clinical trial and comply with investigator-provided instructions. Exclusion Criteria: * Goal eye diagnosed as angle-closure glaucoma, glaucomatocyclitic crisis, ocular hypertension, or secondary glaucoma. * Active herpetic keratitis in the goal eye within 1 year prior to screening, or receiving antiviral therapy at screening. * Active or recurrent ocular infection in either eye that may interfere with trial evaluations (e.g., iridocyclitis, conjunctivitis, keratitis, uveitis, endophthalmitis). * Disease in either eye preventing adequate examination of the fundus or anterior segment. * Fundus disorders in the goal eye that may cause severe visual loss or interfere with efficacy/safety assessments (e.g., pathological myopia, diabetic retinopathy, central retinal vein/artery occlusion, retinal detachment, retinitis pigmentosa, non-glaucomatous optic neuropathy, choroidal melanoma, hematological or vascular diseases). * Monocular subjects. * Ocular infection or corneal-iris-lens lesions in the goal eye judged by the investigator to interfere with efficacy or safety evaluations of the study. * Corneal surgery on the goal eye within 3 months before screening (e.g., PRK, LASIK, SMILE, corneal cross-linking, radial keratotomy); or other conditions affecting intraocular pressure measurement (e.g., corneal edema, corneal scar, keratoconus). * History of retinal laser surgery covering the macular region in the goal eye. * Intraocular surgery on the goal eye (e.g., cataract surgery, fundus surgery) or ocular trauma within 3 months before screening; or planned ocular surgery during the study period. * Glaucoma laser therapy (e.g., laser trabeculoplasty) performed on the goal eye within 1 year prior to screening. * Filtering surgery for glaucoma on the goal eye within 1 year prior to screening (e.g., trabeculectomy, non-penetrating trabeculectomy, glaucoma drainage device implantation, cyclophotocoagulation). * Known or suspected allergy to any component of the study drug or placebo. * Initiation of neurotrophic medications within 28 days before screening or anticipated during the trial (e.g., nerve growth factor other than study drug, brimonidine eye drops, coenzyme Q, ginkgo biloba extract, citicoline, nicotinamide, mecobalamin, autologous serum eye drops, deproteinized calf blood extract-related preparations). * Discontinuation period of prior growth-factor-based therapy does not exceed 5 half-lives AND/OR 14 days (the longer of 5 half-lives and 14 days shall be applied). * Unwilling or unable to discontinue contact lens wear (including cosmetic contact lenses) throughout the study. * Receiving systemic corticosteroids or other immunosuppressive agents. * Poorly-controlled hypertension: systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥100 mmHg despite pharmacological treatment. * Severe cardiovascular, hepatic, renal, or hematological disorders; poorly-controlled diabetes (random blood glucose \>11.1 mmol/L at screening, HbA1c \>8%, or insulin-dependent glycemic control). * Positive for HBeAg, HCV-Ab, HIV antibody, or TP-Ab. * Unable to complete trial procedures due to severe psychiatric or language barriers. * Participation in another clinical trial within 30 days prior to screening. * Cigarette consumption \>10 cigarettes per day within 3 months before screening, or alcohol intake \>14 alcohol units per week (1 unit =10 mL ethanol =200 mL 5%-ABV beer =25 mL 40%-ABV spirits =83 mL 12%-ABV wine). * History of malignancy (excluding basal cell carcinoma), unless treatment was completed at least 2 years prior to screening. * Ongoing chemotherapy. * History of drug dependence, drug abuse, or illicit-drug use within 5 years prior to screening. * Female subjects who are pregnant, lactating, or with positive serum pregnancy test. * Subjects deemed unsuitable for participation by the investigator.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
9 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beijing Tongren Hospital, Capital Medical University
RECRUITINGBeijing, Beijing Municipality, China
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Eye Hospital, Wenzhou Medical University
RECRUITINGWenzhou, Zhejiang, 325027, China
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Joint Shantou International Eye Center of Shantou University and The Chinese University of Hong Kong
RECRUITINGShantou, Guangdong, China
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Peking University First Hospital
RECRUITINGBeijing, Beijing Municipality, China
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Peking University Third Hospital
RECRUITINGBeijing, Beijing Municipality, China
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The Second Affiliated Hospital, Zhejiang University School of Medicine
RECRUITINGHangzhou, Zhejiang, China
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Tianjin Eye Hospital
RECRUITINGTianjin, Tianjin Municipality, China
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Xiangya Hospital of Central South University
RECRUITINGChangsha, Hunan, China
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Zhongshan Ophthalmic Center, Sun Yat-sen University
RECRUITINGGuangzhou, Guangdong, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Home Eye-Pressure checks could slow glaucoma vision loss
- Can a One-Time gene edit stop glaucoma in its tracks?
- Zapping the brain to steady the steps of glaucoma patients?
- Can a tiny eye implant replace glaucoma drops?
- Which eye implant best tames glaucoma? a head-to-head trial aims to find out.
- Could a simple home workout protect eyesight in glaucoma?