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

May 12, 2026 updated by: Santen Pharmaceutical Co., Ltd.

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.

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

345

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Investigational Product: 0.002% 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
Active Control: 0.005% Latanoprost Eye Drops

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraocular Pressure (IOP) at Week 4
Time Frame: Week 4
Change from Baseline in Mean Diurnal IOP at Week 4
Week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change in Intraocular Pressure (IOP)
Time Frame: Week 4
Percent Change from Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 4
Week 4
Change and Percent Change in Intraocular Pressure (IOP)
Time Frame: Post baseline Visits except Week 4
Change and Percent Change from Baseline in Mean Diurnal IOP at each post baseline visit except week 4.
Post baseline Visits except Week 4
Change and Percent Change from baseline in Intraocular Pressure (IOP)
Time Frame: Assessment time point at each post baseline visit.
Change and Percent Change from baseline in IOP at each IOP assessment time point at each post baseline visit.
Assessment time point at each post baseline visit.
Percentage of Responders
Time Frame: Each Post Baseline Visit.
Percentage of Responders (percent reduction from baseline in Mean Diurnal IOP: ≥20%, ≥25%, ≥30%) at each post baseline visit.
Each Post Baseline Visit.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Santen Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 28, 2024

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Study Registration Dates

First Submitted

October 29, 2024

First Submitted That Met QC Criteria

October 29, 2024

First Posted (Actual)

October 31, 2024

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0117B02CN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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