Back to resultsA Phase III Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution Compared With Latanoprost Ophthalmic Solution in Subjects With OAG or OHT
Primary Purpose
Open Angle Glaucoma or Ocular Hypertension
Status
Completed
Phase
Phase 3
Locations
Singapore
Study Type
Interventional
Intervention
DE-117
Latanoprost ophthalmic solution
Sponsored by
About this trial
This is an interventional treatment trial for Open Angle Glaucoma or Ocular Hypertension
Eligibility Criteria
Inclusion Criteria:
- Patients with open angle glaucoma or ocular hypertension in both eyes
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 2
Arm Type
Experimental
Active Comparator
Arm Label
DE-117 ophthalmic solution
Latanoprost ophthalmic solution 0.005%
Arm Description
Outcomes
Primary Outcome Measures
Mean diurnal intraocular pressure
Secondary Outcome Measures
Full Information
NCT ID
NCT02981446
First Posted
December 1, 2016
Last Updated
June 9, 2019
Sponsor
Santen Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02981446
Brief Title
A Phase III Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution Compared With Latanoprost Ophthalmic Solution in Subjects With OAG or OHT
Official Title
A Phase III, Randomized, Observer-Masked, Active-Controlled, Parallel-Group, Multinational and Multicenter Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution 0.002% Compared With Latanoprost Ophthalmic Solution 0.005% in Subjects With Open-Angle Glaucoma or Ocular Hypertension- PEONY Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
November 2016 (undefined)
Primary Completion Date
January 2019 (Actual)
Study Completion Date
January 2019 (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 purpose of this study is to investigate the intraocular pressure-lowering effect and the safety of DE-117 ophthalmic solution compared with Latanoprost ophthalmic solution in subjects with open angle glaucoma or ocular hypertension.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open Angle Glaucoma or Ocular Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
370 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DE-117 ophthalmic solution
Arm Type
Experimental
Arm Title
Latanoprost ophthalmic solution 0.005%
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
DE-117
Intervention Description
DE-117 ophthalmic solution will be taken one drop, once daily for 3 months in both eyes.
Intervention Type
Drug
Intervention Name(s)
Latanoprost ophthalmic solution
Other Intervention Name(s)
Xalatan
Intervention Description
Latanoprost ophthalmic solution will be taken one drop, once daily for 3 months in both eyes.
Primary Outcome Measure Information:
Title
Mean diurnal intraocular pressure
Time Frame
Month 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with open angle glaucoma or ocular hypertension in both eyes
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
Singapore
Country
Singapore
12. IPD Sharing Statement
Learn more about this trial
A Phase III Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution Compared With Latanoprost Ophthalmic Solution in Subjects With OAG or OHT
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