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
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
1 other identifier
interventional
370
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2016
CompletedFirst Posted
Study publicly available on registry
December 5, 2016
CompletedStudy Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2019
CompletedResults Posted
Study results publicly available
March 15, 2024
CompletedMarch 15, 2024
June 1, 2019
2 years
December 1, 2016
August 2, 2023
March 14, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Mean Diurnal IOP at Month 3
The IOP (mmHg) measured in the study eye (identified at Day 1 \[baseline\]) was the efficacy measure for this study. The IOP was measured using a calibrated Goldmann applanation tonometer preferably by the same Investigator (operator) and the same authorized study staff (recorder) during the study for each subject.
Month 3 (average of IOP at 3 time points: 09:00, 13:00, 17:00)
Secondary Outcomes (2)
IOP at 9 Timepoints (First Key Secondary Efficacy Endpoint)
09:00, 13:00, and 17:00 at Week 1, Week 6, and Month 3.
Mean Diurnal IOP at Week 1 (Second Key Secondary Endpoint)
Week 1
Study Arms (2)
DE-117 ophthalmic solution
EXPERIMENTALLatanoprost ophthalmic solution 0.005%
ACTIVE COMPARATORInterventions
DE-117 ophthalmic solution will be taken one drop, once daily for 3 months in both eyes.
Latanoprost ophthalmic solution will be taken one drop, once daily for 3 months in both eyes.
Eligibility Criteria
You may qualify if:
- Patients with open angle glaucoma or ocular hypertension in both eyes
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Singapore, Singapore
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director of R&D Quality Management
- Organization
- Santen Inc
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 1, 2016
First Posted
December 5, 2016
Study Start
January 1, 2017
Primary Completion
January 1, 2019
Study Completion
January 1, 2019
Last Updated
March 15, 2024
Results First Posted
March 15, 2024
Record last verified: 2019-06