A 28 Day Study of ONO-9054 Ophthalmic Solution in Subjects With Ocular Hypertension (OHT) or Open-angle Glaucoma (OAG)
NCT ID: NCT02083289
Last Updated: 2016-02-25
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
PHASE2
123 participants
INTERVENTIONAL
2014-05-31
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
DOUBLE
Study Groups
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Experimental Arm 1
ONO-9054 eye drop solution, 30 µg/mL (0.003%), once daily in both eyes, for 28 days.
ONO-9054
Active Comparator Arm 2
Latanoprost eye drop solution, 0.005%, once daily in both eyes for 28 days.
Latanoprost
Interventions
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ONO-9054
Latanoprost
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Confirmed diagnosis of bilateral OHT or mild to moderate chronic OAG
* Able to undergo washout of all ocular drugs
* An IOP ≥ 24 mmHg at 8:00 AM and ≥ 21 mmHg at 10:00 AM in at least 1 eye; but \< 36 mmHg in both eyes at both Day -5 and Day 1
* Central corneal thickness 500-620 µm at screening and Day -5 in both eyes
* Best corrected visual acuity (BCVA) of +0.7 Log Mar or better
Exclusion Criteria
* History of angle closure or ocular laser surgery within the past 3 months or any refractive surgery procedure within the past 6 months of Screening Visit in the study eye(s)
* Cataracts that prevent observation or photography of the fundus in either eye
18 Years
85 Years
ALL
No
Sponsors
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Ono Pharmaceutical Co. Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Ono Pharmaceutical Co., Ltd.
Role: STUDY_DIRECTOR
Ono Pharmaceutical Co. Ltd
Locations
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Los Angeles Clinical Site
Los Angeles, California, United States
Mission Hills Clinical Site
Mission Hills, California, United States
Newport Beach Clinical Site
Newport Beach, California, United States
Pasadena Clinical Site
Pasadena, California, United States
Petaluma Clinical Site
Petaluma, California, United States
Morrow Clinical Site
Morrow, Georgia, United States
Roswell Clinical Site
Roswell, Georgia, United States
New York Clinical Site
New York, New York, United States
High Point Clinical Site
High Point, North Carolina, United States
Cranberry Township Clinical Site
Cranberry Township, Pennsylvania, United States
Philadelphia Clinical Site
Philadelphia, Pennsylvania, United States
Austin Clinical Site
Austin, Texas, United States
Countries
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References
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Miller Ellis E, Berlin MS, Ward CL, Sharpe JA, Jamil A, Harris A. Ocular hypotensive effect of the novel EP3/FP agonist ONO-9054 versus Xalatan: results of a 28-day, double-masked, randomised study. Br J Ophthalmol. 2017 Jun;101(6):796-800. doi: 10.1136/bjophthalmol-2016-309023. Epub 2016 Sep 20.
Other Identifiers
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ONO-9054IOU003
Identifier Type: -
Identifier Source: org_study_id
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