Safety/Efficacy Study: OPA-6566 Ophthalmic Solution in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension
NCT ID: NCT01410188
Last Updated: 2014-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
160 participants
INTERVENTIONAL
2011-09-30
2012-10-31
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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OPA-6566 low dose
Treatment with OPA-6566 low dose
OPA-6566
OPA-6566, 2 dosing schedules (one drop once per day for 2 weeks and twice per day for 2 weeks)
OPA-6566 medium dose
Treatment with OPA-6566 medium dose
OPA-6566
OPA-6566, 2 dosing schedules (one drop once per day for 2 weeks and twice per day for 2 weeks)
OPA-6566 high dose
Treatment with OPA-6566 high dose
OPA-6566
OPA-6566, 2 dosing schedules (one drop once per day for 2 weeks and twice per day for 2 weeks)
Latanoprost
Treatment with Latanoprost
Latanoprost
Latanoprost (one drop once per day for 4 weeks)
Placebo
Placebo
Placebo
Placebo, 2 dosing schedules (one drop once per day for 2 weeks and twice per day for 2 weeks)
OPA-6566 additional dose
Treatment with OPA-6566 additional dose
OPA-6566
OPA-6566, 2 dosing schedules (one drop once per day for 2 weeks and twice per day for 2 weeks)
Interventions
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OPA-6566
OPA-6566, 2 dosing schedules (one drop once per day for 2 weeks and twice per day for 2 weeks)
Placebo
Placebo, 2 dosing schedules (one drop once per day for 2 weeks and twice per day for 2 weeks)
Latanoprost
Latanoprost (one drop once per day for 4 weeks)
Eligibility Criteria
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Inclusion Criteria
* diagnosis of ocular hypertension as defined in the protocol
Exclusion Criteria
* other ocular conditions as defined by the protocol
18 Years
75 Years
ALL
No
Sponsors
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Otsuka Pharmaceutical Co., Ltd.
INDUSTRY
Kubota Vision Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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John W Chandler, MD
Role: STUDY_DIRECTOR
Kubota Vision Inc.
Locations
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Artesia, California, United States
Glendale, California, United States
Roswell, Georgia, United States
Louisville, Kentucky, United States
Washington, Missouri, United States
High Point, North Carolina, United States
Maryville, Tennessee, United States
Austin, Texas, United States
San Antonio, Texas, United States
Countries
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Other Identifiers
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OPA-6566-101
Identifier Type: -
Identifier Source: org_study_id
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