- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02822742
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
November 16, 2017 updated by: Santen Pharmaceutical Co., Ltd.
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
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
26
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
-
-
-
Tokyo, Japan
-
-
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
20 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: DE-117 ophthalmic solution and Latanoprost
DE-117 is Experimental.
Latanoprost is Active Comparator.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Intraocular pressure
Time Frame: Week 4
|
Week 4
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
July 2, 2016
Primary Completion (ACTUAL)
April 28, 2017
Study Completion (ACTUAL)
April 28, 2017
Study Registration Dates
First Submitted
June 30, 2016
First Submitted That Met QC Criteria
July 1, 2016
First Posted (ESTIMATE)
July 4, 2016
Study Record Updates
Last Update Posted (ACTUAL)
November 20, 2017
Last Update Submitted That Met QC Criteria
November 16, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01171506
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.
Clinical Trials on Primary Open Angle Glaucoma or Ocular Hypertension
-
Aerie PharmaceuticalsCompletedPrimary Open Angle Glaucoma or Ocular HypertensionUnited States
-
Maisonneuve-Rosemont HospitalRecruitingPatients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)Canada
-
Aerie PharmaceuticalsCompletedPrimary Open Angle Glaucoma or Ocular HypertensionUnited States
-
Qlaris Bio, Inc.RecruitingPrimary Open Angle Glaucoma of Both Eyes | Primary Open Angle Glaucoma (POAG) | Primary Open-Angle Glaucoma, Unspecified Eye | Ocular Hypertension (OHT)United States
-
Santen Pharmaceutical Co., Ltd.CompletedPrimary Open Angle Glaucoma, Ocular HypertensionJapan
-
Santen Inc.CompletedPrimary Open-angle Glaucoma and Ocular HypertensionUnited States
-
Santen Inc.Completed
-
Daniel MoorePfizerTerminatedPrimary Open Angle Glaucoma (POAG) | Ocular Hypertension (OHT)United States
-
Inotek Pharmaceuticals CorporationCompletedOcular Hypertension (OHT) | Primary Open-Angle Glaucoma (POAG)United States
-
Inotek Pharmaceuticals CorporationCompletedOcular Hypertension (OHT) | Primary Open-Angle Glaucoma (POAG)United States
Clinical Trials on DE-117 ophthalmic solution
-
Santen Inc.CompletedOcular Hypertension | Open-angle GlaucomaUnited States
-
Santen Inc.CompletedPrimary Open-angle Glaucoma and Ocular HypertensionUnited States
-
Santen Pharmaceutical Co., Ltd.CompletedPrimary Open Angle Glaucoma | Ocular HypertensionJapan
-
Santen Inc.Completed
-
Santen Inc.CompletedOpen-angle Glaucoma or Ocular HypertensionUnited States
-
Santen Pharmaceutical Co., Ltd.CompletedOpen Angle Glaucoma or Ocular HypertensionSingapore
-
Santen Pharmaceutical Co., Ltd.Completed
-
Santen Pharmaceutical Co., Ltd.CompletedOcular Hypertension | Open-Angle GlaucomaJapan
-
Santen Inc.CompletedOpen-angle Glaucoma, Ocular HypertensionUnited States, Japan
-
Santen Inc.CompletedOcular Hypertension | Open-Angle GlaucomaUnited States