MedDataX Logo

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

NCT ID: NCT02822742

Last Updated: 2017-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-02

Study Completion Date

2017-04-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Primary Open Angle Glaucoma or Ocular Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

DE-117 ophthalmic solution and Latanoprost

DE-117 is Experimental. Latanoprost is Active Comparator.

Group Type OTHER

DE-117 ophthalmic solution

Intervention Type DRUG

Latanoprost ophthalmic solution 0.005%

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

DE-117 ophthalmic solution

Intervention Type DRUG

Latanoprost ophthalmic solution 0.005%

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Santen Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Tokyo, , Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

References

Explore related publications, articles, or registry entries linked to this study.

Aihara M, Ropo A, Lu F, Kawata H, Iwata A, Odani-Kawabata N, Shams N. Intraocular pressure-lowering effect of omidenepag isopropyl in latanoprost non-/low-responder patients with primary open-angle glaucoma or ocular hypertension: the FUJI study. Jpn J Ophthalmol. 2020 Jul;64(4):398-406. doi: 10.1007/s10384-020-00748-x. Epub 2020 Jun 22.

Reference Type DERIVED
PMID: 32572719 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

01171506

Identifier Type: -

Identifier Source: org_study_id