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
NCT ID: NCT02981446
Last Updated: 2024-03-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
370 participants
INTERVENTIONAL
2017-01-31
2019-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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DE-117 ophthalmic solution
DE-117
DE-117 ophthalmic solution will be taken one drop, once daily for 3 months in both eyes.
Latanoprost ophthalmic solution 0.005%
Latanoprost ophthalmic solution
Latanoprost ophthalmic solution will be taken one drop, once daily for 3 months in both eyes.
Interventions
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DE-117
DE-117 ophthalmic solution will be taken one drop, once daily for 3 months in both eyes.
Latanoprost ophthalmic solution
Latanoprost ophthalmic solution will be taken one drop, once daily for 3 months in both eyes.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients with severe visual field defect
* Patients with any diseases that preclude participation in this study for safety reasons
18 Years
ALL
No
Sponsors
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Santen Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Singapore, , Singapore
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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01171505
Identifier Type: -
Identifier Source: org_study_id
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