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New eye drop shows promise for glaucoma control in chinese patients

NCT ID NCT06666855

Disease control Sponsor: Santen Pharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new eye drop called DE-117B in 345 Chinese adults with open-angle glaucoma or high eye pressure. The goal is to see if it safely lowers eye pressure better than an existing drug. Participants use the drops once daily for at least 4 weeks, with long-term follow-up. This is a disease-control treatment, not a cure, so patients will need to keep using medication to manage their condition.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

345 people

The number who actually took part.

Started

Nov 2024

Expected to finish

Aug 2026

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 years and older

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: * Patients diagnosed with primary open angle glaucoma or ocular hypertension in both eyes. * Corrected visual acuity ≥0.2 in both eyes. * Anterior chamber angle grade ≥2 (Shaffer scale) in both eyes. * Central corneal thickness ≥480 μm to ≤600 μm in both eyes. * At completion of the washout phase, IOP ≥22 mmHg in at least one eye and ≤34 mmHg in both eyes at all measurement time points. Exclusion Criteria: * Consider visual field disorder at risk for progression during the study based on the current clinical examination result. * Severe visual field disorder (e.g., mean deviation lower than -12 dB, as assessed by Humphrey field analyzer). * Any corneal abnormality or other condition potentially interfering with reliable applanation tonometry. * History of iritis or uveitis. * Presence of any active external ocular disease, inflammation, or infection of the eye or eyelids. * History of macular oedema, retinal detachment, or diabetic retinopathy, or current retinal disease at risk for progression during the study. * History of refractive keratotomy. * History of invasive surgery for glaucoma (including laser therapy). * Anterior segment or intraocular surgery (other than glaucoma) within 90 days prior to start of washout phase. * History of severe eye injury. * History of allergy to agents that were to be used during the study (e.g., benzalkonium chloride, instillation anesthetics, fluorescein, latanoprost eye drops). * Intended use of prohibited concomitant medications or therapies during the study. * Required use of contact lenses from 1 week before treatment phase initiation and during the study. * Pseudophakic eye, aphakic eye. * Current participation in another clinical study, or participation and treatment with study medication within 90 days before the start of the washout phase. * Females who are pregnant, nursing, or potentially pregnant (e.g., positive pregnancy test), planning a pregnancy during the study, or unable to use appropriate contraception during the study.

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Conditions

The condition(s) this trial relates to.

ocular hypertension open-angle glaucoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ocular hypertension Open angle glaucoma

Contacts and locations

Locations

  • Affiliated Hospital of Guizhou Medical University

    Guiyang, China

  • Aier Eye Hospital (Liaoning)

    Shenyang, China

  • Beijing Chao-Yang Hospital, Capital Medical University

    Beijing, China

  • Beijing Hospital

    Beijing, China

  • Beijing Tongren Hospital, Capital Medical University

    Beijing, China

  • Daqing People's Hospital

    Heilongjiang, China

  • Jinan Second People's Hospital (Jinan eye hospital)

    Jinan, China

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

    Shantou, China

  • Luoyang third people's hospital

    Luoyang, China

  • Peking University Third Hospital

    Beijing, China

  • Qingdao Eye Hospital of Shandong First Medical University

    Qingdao, China

  • Shanghai Eye Disease Prevention And Treatment Center/Shanghai Eye Hospital

    Shanghai, China

  • Shanxi eye hospital

    Shanxi, China

  • Shenzhen Eye Hospital

    Shenzhen, China

  • The 4th People's Hospital of Shenyang

    Shenyang, China

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, China

  • The Second Hospital & Clinical Medicial Lanzhou University

    Lanzhou, China

  • Tianjin Eye Hospital

    Tianjin, China

  • Wuhan Aier Eye Hospital

    Wuhan, China

  • Wuhan Puren Hospital

    Wuhan, China

  • Wuxi Second People's Hospital

    Wuxi, China

  • Zhejiang Provincial People's Hospital

    Hangzhou, China

  • Zhongnan Hospital Affiliated to Wuhan University

    Wuhan, China

  • Zhongshan Ophthalmic Center

    Guangzhou, China

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Other studies related to the condition(s) this trial covers.