A Study to Assess Intraocular Pressure and Ocular Safety of the Beta-3 Agonist Mirabegron in Research Subjects
NCT ID: NCT01284309
Last Updated: 2013-12-11
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
321 participants
INTERVENTIONAL
2010-11-30
2011-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
QUADRUPLE
Study Groups
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Mirabegron
Mirabegron
oral
Placebo
Placebo
oral
Interventions
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Mirabegron
oral
Placebo
oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male subject with female spouses/partners who are of childbearing potential must use contraception consisting of two forms of birth control (one of which must be a barrier method) during the study period
* Subject may either be otherwise healthy or have symptoms of overactive bladder by self-report
Exclusion Criteria
* Abnormal visual field in either eye
* Ophthalmic condition that would interfere with reliable Goldmann tonometry (e.g., corneal edema, uveitis, severe keratoconjunctivitis sicca)
* History of major ocular infection, inflammation, or herpes simplex keratitis; evidence of current clinically significant blepharitis or conjunctivitis
* Any history of ocular surgery including refractive surgery such as laser-assisted in situ keratomileusis (LASIK) or photorefractive keratectomy (PRK) in any eye
* Ocular trauma within the past six months
* Severe myopia
* Diabetes, Type I or Type 2, with or without medical management
* Cardiovascular disease requiring pharmacotherapy
* History of any type of dysrhythmia
* Systemic hypertension requiring pharmacotherapy
* Past diagnosis of any connective tissue or autoimmune disease including rheumatoid arthritis and spondyloarthropathies
* History of psychiatric illness requiring hospitalization
* Recent history (within past 24 months) of alcohol or other substance abuse (with the exception of nicotine)
* Used tobacco-containing products or nicotine-containing products within past 3 months
* Has been part of any clinical study past within 30 days or currently taking part in a clinical study other than the present study, or has participated in any previous study with mirabegron at any time
* Ocular medication of any kind within past 30 days
18 Years
ALL
Yes
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Astellas Pharma Global Development
Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Astellas Pharma Global Development
Locations
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Celerion
Tempe, Arizona, United States
Celerion
Lincoln, Nebraska, United States
Countries
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References
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Novack GD, Lewis RA, Vogel R, Sheth N, Swearingen D, Rasmussen S, Hantsbarger G, Martin NE. Randomized, double-masked, placebo-controlled study to assess the ocular safety of mirabegron in healthy volunteers. J Ocul Pharmacol Ther. 2013 Sep;29(7):674-80. doi: 10.1089/jop.2012.0254. Epub 2013 Apr 15.
Other Identifiers
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178-CL-081
Identifier Type: -
Identifier Source: org_study_id