Back to resultsA Study Assessing the Safety and Efficacy of DE-117 in Subjects With POAG or OH Who Are Non-/Low-responders to Latanoprost: FUJI Study
Primary Purpose
Primary Open Angle Glaucoma or Ocular Hypertension
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
DE-117 ophthalmic solution
Latanoprost ophthalmic solution 0.005%
Sponsored by
About this trial
This is an interventional treatment trial for Primary Open Angle Glaucoma or Ocular Hypertension
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
DE-117 ophthalmic solution and Latanoprost
Arm Description
DE-117 is Experimental. Latanoprost is Active Comparator.
Outcomes
Primary Outcome Measures
Intraocular pressure
Secondary Outcome Measures
Full Information
NCT ID
NCT02822742
First Posted
June 30, 2016
Last Updated
November 16, 2017
Sponsor
Santen Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02822742
Brief Title
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
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
July 2, 2016 (Actual)
Primary Completion Date
April 28, 2017 (Actual)
Study Completion Date
April 28, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Santen Pharmaceutical Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open Angle Glaucoma or Ocular Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DE-117 ophthalmic solution and Latanoprost
Arm Type
Other
Arm Description
DE-117 is Experimental. Latanoprost is Active Comparator.
Intervention Type
Drug
Intervention Name(s)
DE-117 ophthalmic solution
Intervention Type
Drug
Intervention Name(s)
Latanoprost ophthalmic solution 0.005%
Primary Outcome Measure Information:
Title
Intraocular pressure
Time Frame
Week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
32572719
Citation
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.
Results Reference
derived
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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
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