Clinical trial
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
Name
01171505
Description
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 arms
Trial start
2017-01-01
Estimated PCD
2019-01-01
Trial end
2019-01-01
Status
Completed
Phase
Early phase I
Treatment
DE-117
DE-117 ophthalmic solution will be taken one drop, once daily for 3 months in both eyes.
Arms:
DE-117 ophthalmic solution
Latanoprost ophthalmic solution
Latanoprost ophthalmic solution will be taken one drop, once daily for 3 months in both eyes.
Arms:
Latanoprost ophthalmic solution 0.005%
Other names:
Xalatan
Size
370
Primary endpoint
Mean Diurnal IOP at Month 3
Month 3 (average of IOP at 3 time points: 09:00, 13:00, 17:00)
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}}, 'enrollmentInfo': {'count': 370, 'type': 'ACTUAL'}}
Updated at
2024-03-15
1 organization
2 products
1 indication
Product
DE-117Indication
Open-Angle GlaucomaOrganization
Santen PharmaceuticalProduct
Latanoprost