Can a simple eye drop protect the optic nerve in glaucoma?

NCT ID NCT07777861

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 80 years

Sex

Anyone

Healthy volunteers

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

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.

open-angle glaucoma Optic Nerve Injuries

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.

  1. The places running it

    9 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Beijing Tongren Hospital, Capital Medical University

    RECRUITING

    Beijing, Beijing Municipality, China

  • Eye Hospital, Wenzhou Medical University

    RECRUITING

    Wenzhou, Zhejiang, 325027, China

  • Joint Shantou International Eye Center of Shantou University and The Chinese University of Hong Kong

    RECRUITING

    Shantou, Guangdong, China

  • Peking University First Hospital

    RECRUITING

    Beijing, Beijing Municipality, China

  • Peking University Third Hospital

    RECRUITING

    Beijing, Beijing Municipality, China

  • The Second Affiliated Hospital, Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, China

  • Tianjin Eye Hospital

    RECRUITING

    Tianjin, Tianjin Municipality, China

  • Xiangya Hospital of Central South University

    RECRUITING

    Changsha, Hunan, China

  • Zhongshan Ophthalmic Center, Sun Yat-sen University

    RECRUITING

    Guangzhou, Guangdong, China

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