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Open Angle GlaucomaPhase 3NCT06666855

A Phase III Study in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension in China

A Phase 3 study testing DE-117B Eye Drops and Latanoprost in people with Open Angle Glaucoma and Ocular Hypertension, run by Santen Pharmaceutical Co., Ltd. at 24 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a Phase III Study that includes a single arm, open-label, multi-dose PK study cohort and a randomized, evaluator-masked, active drug-control multicenter study. Subjects diagnosed with POAG (Primary Open Angle Glaucoma) or OHT (Ocular Hypertension) who meet eligibility criteria will washout of their current IOP… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Open Angle Glaucoma, Ocular Hypertension
What is being tested?
DE-117B Eye Drops and Latanoprost
Could I receive a placebo?
No, everyone receives an active treatment
How many people
345 participants
Where
24 sitesChina
Study dates
28 Nov 2024to 31 Aug 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 16Show fewer
  • 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.

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

China24 sites

  • Beijing Chao-Yang Hospital, Capital Medical University

    Beijing

  • Beijing Hospital

    Beijing

  • Beijing Tongren Hospital, Capital Medical University

    Beijing

  • Peking University Third Hospital

    Beijing

  • Zhongshan Ophthalmic Center

    Guangzhou

  • Affiliated Hospital of Guizhou Medical University

    Guiyang

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou

  • Zhejiang Provincial People's Hospital

    Hangzhou

  • Daqing People's Hospital

    Heilongjiang

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

    Jinan

  • The Second Hospital & Clinical Medicial Lanzhou University

    Lanzhou

  • Luoyang third people's hospital

    Luoyang

  • Qingdao Eye Hospital of Shandong First Medical University

    Qingdao

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

    Shanghai

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

    Shantou

  • Shanxi eye hospital

    Shanxi

  • Aier Eye Hospital (Liaoning)

    Shenyang

  • The 4th People's Hospital of Shenyang

    Shenyang

  • Shenzhen Eye Hospital

    Shenzhen

  • Tianjin Eye Hospital

    Tianjin

  • Wuhan Aier Eye Hospital

    Wuhan

  • Wuhan Puren Hospital

    Wuhan

  • Zhongnan Hospital Affiliated to Wuhan University

    Wuhan

  • Wuxi Second People's Hospital

    Wuxi

Other trials in China

About this study

Official title: A Phase III Study Including a Single-Arm, Open-Label, Multi-Dose PK Study Cohort and a Randomized, Evaluator-Masked, Active Drug Controlled, Parallel Group, Multicenter, Bridging Study Cohort With a Long-term Follow-up Phase Assessing the Efficacy and Safety of DE-117B Eye Drops in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension in China

This is a Phase III Study that includes a single arm, open-label, multi-dose PK study cohort and a randomized, evaluator-masked, active drug-control multicenter study.

Subjects diagnosed with POAG (Primary Open Angle Glaucoma) or OHT (Ocular Hypertension) who meet eligibility criteria will washout of their current IOP lowering medication(s), if any.

Read more

The study will investigate plasma pharmacokinetics of multi-dose 0.002% DE-117B eye drops (1 drop at a time administered once daily for 7 days) in Chinese subjects with primary open angle glaucoma or ocular hypertension.

It will investigate the safety of multi-dose 0.002% DE-117B eye drops (1 drop at a time administered once daily for 7 days) in Chinese subjects with primary open angle glaucoma or ocular hypertension.

There will be a bridging cohort and extension follow-up phase

Being tested
DE-117B Eye Drops, Latanoprost
Medical subject headings
Glaucoma, Open-Angle, Ocular Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DE-117B Eye DropsDrug

    Investigational Product: 0.002% DE-117B Eye Drops

  • LatanoprostDrug

    Active Control: 0.005% Latanoprost Eye Drops

Study groups in NCT06666855
Study groupRoleWhat they receive
DE-117B Eye DropsExperimental0.002% DE-117B Eye Drops - One drop daily, 9:00 PM±1 hours instilled in both eyes for 4 weeks, followed by 0.002% DE-117B Eye Drops - One drop daily, 9:00 PM±1 hours instilled in both eyes for an extension follow-up phase of 12 months.
Receives: Drug: DE-117B Eye Drops
Latanoprost Eye DropsActive comparator0.005% Latanoprost Eye Drops - One drop daily, 9:00 PM±1 hours instilled in both eyes for 4 weeks, followed by 0.002% DE-117B Eye Drops - One drop daily, 9:00 PM±1 hours instilled in both eyes for an extension follow-up phase of 12 months.
Receives: Drug: Latanoprost

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intraocular Pressure (IOP) at Week 4

    Change from Baseline in Mean Diurnal IOP at Week 4

    Measured: Week 4

Secondary outcomes (4)

  1. Percent Change in Intraocular Pressure (IOP)

    Percent Change from Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 4

    Measured: Week 4

  2. Change and Percent Change in Intraocular Pressure (IOP)

    Change and Percent Change from Baseline in Mean Diurnal IOP at each post baseline visit except week 4.

    Measured: Post baseline Visits except Week 4

  3. Change and Percent Change from baseline in Intraocular Pressure (IOP)

    Change and Percent Change from baseline in IOP at each IOP assessment time point at each post baseline visit.

    Measured: Assessment time point at each post baseline visit.

  4. Percentage of Responders

    Percentage of Responders (percent reduction from baseline in Mean Diurnal IOP: ≥20%, ≥25%, ≥30%) at each post baseline visit.

    Measured: Each Post Baseline Visit.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2024
  2. Study start28 Nov 2024
  3. Primary completion31 Aug 2026 (estimated)
  4. Study completion31 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
345 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06666855
Sponsor's protocol ID
0117B02CN
Status last verified
May 2026
First submitted
29 Oct 2024
Last updated
15 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing DE-117B Eye Drops and Latanoprost in people with Open Angle Glaucoma and Ocular Hypertension, run by Santen Pharmaceutical Co., Ltd. at 24 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intraocular Pressure (IOP) at Week 4 (time frame: Week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06666855.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.

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Clinical Trial NCT06666855 | AzTrials