A Study Assessing the Safety and Efficacy of DE-117 in Subjects With POAG or OH Who Are Non-/Low-responders to Latanoprost: FUJI Study

A Phase III, Open-label, Single-arm, Multi-center Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension Who Are Non-/Low-responders to Latanoprost Ophthalmic Solution: FUJI Study

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02822742

Enrollment

Registered

2016-07-04

Start date

2016-07-02

Completion date

2017-04-28

Last updated

2017-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Open Angle Glaucoma or Ocular Hypertension

Brief summary

The purposes of this study are to investigate the effect of intraocular pressure lowering efficacy and safety of DE-117 ophthalmic solution in subjects with primary open-angle glaucoma or ocular hypertension who are non-/low-responders to latanoprost ophthalmic solution.

Interventions

DRUGDE-117 ophthalmic solution

DRUGLatanoprost ophthalmic solution 0.005%

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

* Primary open angle glaucoma or ocular hypertension

Exclusion criteria

* Patients at risk of progression of visual field loss * Patients with severe visual field defect * Patients with any diseases that preclude participation in this study for safety reasons

Design outcomes

Primary

Measure	Time frame
Intraocular pressure	Week 4

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026