---
title: A Study of DE-111A on the Treatment of Open Angle Glaucoma or Ocular Hypertension
nct_id: NCT03822559
overall_status: COMPLETED
phase: PHASE3
sponsor: Santen Pharmaceutical Co., Ltd.
study_type: INTERVENTIONAL
primary_condition: Open-angle Glaucoma, Ocular Hypertension
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03822559.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03822559"
ct_last_update_post_date: 2023-07-14
last_seen_at: "2026-05-12T06:12:09.585Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Study of DE-111A on the Treatment of Open Angle Glaucoma or Ocular Hypertension

**Official Title:** A Randomized, Double-masked, Controlled Parallel Group, Multi-center Study of DE-111A (Fixed Dose Combination of Tafluprost and Timolol Eye Drops) on the Treatment of Open Angle Glaucoma or Ocular Hypertension (With Tafluprost Eye Drops as a Comparator)

**NCT ID:** [NCT03822559](https://clinicaltrials.gov/study/NCT03822559)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 219
- **Lead Sponsor:** Santen Pharmaceutical Co., Ltd.
- **Conditions:** Open-angle Glaucoma, Ocular Hypertension
- **Start Date:** 2019-01-20
- **Completion Date:** 2023-04-04
- **CT.gov Last Update:** 2023-07-14

## Brief Summary

The objective of this study is to investigate whether the IOP (intraocular pressure) -lowering effect of DE-111A (preservative-free fixed dose combination of 0.0015% tafluprost and 0.5% timolol eye drops, administered one drop a time, once daily for 3 months) is superior to the monotherapy of tafluprost 0.0015% eye drops administered one drop a time, once daily for 3 months) in subjects with open-angle glaucoma or ocular hypertension in China as well as comparison of safety.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Diagnosis of open angle glaucoma (including primary open angle glaucoma, exfoliation glaucoma or pigmentary glaucoma) in one or both eyes or ocular hypertension for which the subject has been using prostaglandin or beta-adrenergic blocker IOP (intraocular pressure) -lowering drugs before the screening visit
* Those who have signed the informed consent form

Exclusion Criteria:

* Women who are pregnant, nursing or planning pregnancy, or women of child-bearing potential who are not using a reliable method of contraception
* Anterior chamber angle in either eye to be treated with the level \<2 according to Shaffer classification as measured by gonioscopy
* Corneal disorder or other disease preventing reliable applanation tonometry in the treated eyes, including refractive surgery of ocular anterior segment)
* Alcohol or drug abuse
* Current participation in another clinical trial involving an investigational drug/device, or participation in such a trial within 30 days before Screening visit
```

## Arms

- **DE-111A eye drops** (EXPERIMENTAL)
- **0.0015% tafluprost eye drops** (ACTIVE_COMPARATOR)

## Interventions

- **A preservative-free, a clear, colorless sterile aqueous ophthalmic solution containing 0.015mg of tafluprost and 5.0mg of timolol in 1mL** (DRUG) — One drop a time, once daily administration of DE-111A eye drops in the affected eye(s) at 8:00 am (±1h) for 3 months.
- **A preservative-free, a clear, colorless sterile aqueous ophthalmic solution containing 0.015mg of tafluprost in 1mL** (DRUG) — One drop a time, once daily administration of preservative-free 0.0015% tafluprost eye drops in the affected eye(s) at 8:00 (±1h) for 3 months.

## Primary Outcomes

- **Change from baseline in the average diurnal IOP (intraocular pressure)** _(time frame: Three months)_ — Diurnal IOP measurements will be performed at 8:00 (±1 h), 10:00 (±1 h) and 16:00 (±1 h).

## Locations (2)

- Aier Eye Hospital Group Co., Ltd Changsha Aier Eye Hospital, Changsha, China
- Eye & Ent Hospital of Fudan University, Shanghai, China

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.aier eye hospital group co., ltd changsha aier eye hospital|changsha||china` — added _(2026-05-12)_
- `locations.eye & ent hospital of fudan university|shanghai||china` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT03822559*  
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