Back to resultsA Long-term Study of DE-117 Ophthalmic Solution Monotherapy and Concomitant Use of DE-117 Ophthalmic Solution With Timolol Ophthalmic Solution in Patients With OAG or OH: RENGE Study
Primary Purpose
Open Angle Glaucoma or Ocular Hypertension
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
DE-117 ophthalmic solution
Timolol 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
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 3
Arm Type
Experimental
Experimental
Other
Arm Label
DE-117 ophthalmic solution (Group1)
DE-117 ophthalmic solution (Group2)
DE-117 ophthalmic solution + Timolol (Group3)
Arm Description
Monotherapy
Monotherapy
Concomitant Use
Outcomes
Primary Outcome Measures
Evaluation of adverse events
Secondary Outcome Measures
Full Information
NCT ID
NCT02822729
First Posted
June 30, 2016
Last Updated
November 16, 2017
Sponsor
Santen Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02822729
Brief Title
A Long-term Study of DE-117 Ophthalmic Solution Monotherapy and Concomitant Use of DE-117 Ophthalmic Solution With Timolol Ophthalmic Solution in Patients With OAG or OH: RENGE Study
Official Title
A Long-term Open-label Study of DE-117 Ophthalmic Solution Monotherapy and Concomitant Use of DE-117 Ophthalmic Solution With Timolol Ophthalmic Solution in Patients With Open-angle Glaucoma or Ocular Hypertension : RENGE Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
July 1, 2016 (Actual)
Primary Completion Date
November 9, 2017 (Actual)
Study Completion Date
November 9, 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 evaluate the long-term safety and intraocular pressure-lowering efficacy of DE-117 ophthalmic solution monotherapy and concomitant use of DE-117 ophthalmic solution with timolol ophthalmic solution 0.5% in patients 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
None (Open Label)
Allocation
Randomized
Enrollment
125 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DE-117 ophthalmic solution (Group1)
Arm Type
Experimental
Arm Description
Monotherapy
Arm Title
DE-117 ophthalmic solution (Group2)
Arm Type
Experimental
Arm Description
Monotherapy
Arm Title
DE-117 ophthalmic solution + Timolol (Group3)
Arm Type
Other
Arm Description
Concomitant Use
Intervention Type
Drug
Intervention Name(s)
DE-117 ophthalmic solution
Intervention Type
Drug
Intervention Name(s)
Timolol ophthalmic solution
Primary Outcome Measure Information:
Title
Evaluation of adverse events
Time Frame
Week 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with 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
34495425
Citation
Aihara M, Lu F, Kawata H, Iwata A, Odani-Kawabata N. Twelve-month efficacy and safety of omidenepag isopropyl, a selective EP2 agonist, in open-angle glaucoma and ocular hypertension: the RENGE study. Jpn J Ophthalmol. 2021 Nov;65(6):810-819. doi: 10.1007/s10384-021-00868-y. Epub 2021 Sep 8.
Results Reference
derived
Learn more about this trial
A Long-term Study of DE-117 Ophthalmic Solution Monotherapy and Concomitant Use of DE-117 Ophthalmic Solution With Timolol Ophthalmic Solution in Patients With OAG or OH: RENGE Study
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