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Active, not recruitingNCT06666855Updated May 15, 2026

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

A Phase 3 interventional study of DE-117B Eye Drops and Latanoprost in Open Angle Glaucoma and Ocular Hypertension, sponsored by Santen Pharmaceutical Co., Ltd.. Active, not recruiting at 24 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-15.

Sponsored by Santen Pharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
345
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 lowering medication(s), if any.

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

02

Conditions studied

  • Open Angle Glaucoma
  • Ocular Hypertension
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
345 participants (actual)

Study arms

  • Experimental
    DE-117B Eye Drops

    0.002% 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.

    Drug: DE-117B Eye Drops

  • Active comparator
    Latanoprost Eye Drops

    0.005% 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.

    Drug: Latanoprost

Interventions

  • DrugDE-117B Eye Drops

    Investigational Product: 0.002% DE-117B Eye Drops

  • DrugLatanoprost

    Active Control: 0.005% Latanoprost Eye Drops

05

What researchers measure

Primary outcomes

  1. Intraocular Pressure (IOP) at Week 4

    Change from Baseline in Mean Diurnal IOP at Week 4

    Time frame: Week 4

Secondary outcomes

  1. Percent Change in Intraocular Pressure (IOP)

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

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Each Post Baseline Visit.

06

Study locations

24 sites
  • Beijing Chao-Yang Hospital, Capital Medical University
    Beijing, China
  • Beijing Hospital
    Beijing, China
  • Beijing Tongren Hospital, Capital Medical University
    Beijing, China
  • Peking University Third Hospital
    Beijing, China
  • Zhongshan Ophthalmic Center
    Guangzhou, China
  • Affiliated Hospital of Guizhou Medical University
    Guiyang, China
  • The Second Affiliated Hospital of Zhejiang University School of Medicine
    Hangzhou, China
  • Zhejiang Provincial People's Hospital
    Hangzhou, China
  • Daqing People's Hospital
    Heilongjiang, China
  • Jinan Second People's Hospital (Jinan eye hospital)
    Jinan, China
  • The Second Hospital & Clinical Medicial Lanzhou University
    Lanzhou, China
  • Luoyang third people's hospital
    Luoyang, China
  • Qingdao Eye Hospital of Shandong First Medical University
    Qingdao, China
  • Shanghai Eye Disease Prevention And Treatment Center/Shanghai Eye Hospital
    Shanghai, China
  • Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong
    Shantou, China
  • Shanxi eye hospital
    Shanxi, China
  • Aier Eye Hospital (Liaoning)
    Shenyang, China
  • The 4th People's Hospital of Shenyang
    Shenyang, China
  • Shenzhen Eye Hospital
    Shenzhen, China
  • Tianjin Eye Hospital
    Tianjin, China
  • Wuhan Aier Eye Hospital
    Wuhan, China
  • Wuhan Puren Hospital
    Wuhan, China
  • Zhongnan Hospital Affiliated to Wuhan University
    Wuhan, China
  • Wuxi Second People's Hospital
    Wuxi, China
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06666855
Lead sponsor
Santen Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Oct 31, 2024
Start date
Nov 28, 2024
Primary completion
Aug 31, 2026 (estimated)
Completion
Aug 31, 2026 (estimated)
Last update
May 15, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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