Investigating a new eye drop treatment for glaucoma and ocular hypertension in China

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 study is testing a new eye drop treatment for glaucoma and high eye pressure to see if it’s safe and effective for patients in China.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 338 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Santen Pharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 25 sites (Beijing and 24 other locations)
• Trial ID: NCT06666855 on ClinicalTrials.gov

What this trial studies

This Phase III study evaluates the pharmacokinetics and safety of 0.002% DE-117B eye drops in patients diagnosed with primary open angle glaucoma or ocular hypertension. Participants will undergo a washout of their current intraocular pressure (IOP) lowering medications before receiving the treatment. The study includes a single-arm, open-label cohort and a randomized, evaluator-masked, active drug-control multicenter component. The treatment will be administered once daily for seven days, and there will be a follow-up phase to monitor outcomes.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with primary open angle glaucoma or ocular hypertension who meet specific eligibility criteria.

Not a fit: Patients with severe visual field disorders or other significant ocular conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for managing glaucoma and ocular hypertension.

How similar studies have performed: Other studies have shown success with similar pharmacological approaches in treating glaucoma, indicating potential for this treatment.

Eligibility criteria

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.

Where this trial is running

Beijing and 24 other locations

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

Study contacts

• Study coordinator: Santen Pharmaceuticals Co., Ltd Clinical Operations

Conditions Open Angle Glaucoma; Ocular Hypertension