Clinical trial NCT01284309: A Study to Assess Intraocular Pressure and Ocular Safety of the Beta-3 Agonist Mirabegron in Research Subjects
Official title: A Phase 1b, Randomized, Double-Masked, Parallel Group, Placebo Controlled Study to Assess Intraocular Pressure and Ocular Safety of the Beta-3 Agonist Mirabegron in Research Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Intraocular Pressure
Keywords: Intraocular Pressure (IOP)
YM178
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2011-01-27
Enrollment: 321
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to assess the affect of mirabegron on intraocular pressure (IOP) in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Female subject must be either post-menopausal (defined as at least 2 years without menses) or surgically sterile (at least 1 month) or of childbearing potential with contraception. All women of childbearing potential will be required to use contraception consisting of two forms of birth control (one of which must be a barrier method), must not be lactating, and must not be breastfeeding during the study period and for 30 days after final study drug administration. All women of childbearing potential must have a negative urine pregnancy test
* 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:

* History of glaucoma or ocular hypertension
* 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

Primary outcomes:
measure: Change from baseline to Day 56 in subject-average intraocular pressure (IOP)
timeFrame: Baseline and Day 56
Secondary outcomes:
measure: Change from baseline to Day 10 in subject-average IOP
timeFrame: Baseline and Day 10
measure: Number of subjects experiencing increase from baseline in a single-eye IOP by ≥6mmHg in either eye at Day 10
timeFrame: Baseline and Day 10
measure: Number of subjects experiencing increase from baseline in a single-eye IOP by ≥6mmHg in either eye at Day 56
timeFrame: Baseline and Day 56
measure: Number of subjects experiencing increase from baseline in a single-eye IOP by≥10 mmHg in either eye at Day 10
timeFrame: Baseline and Day 10
measure: Number of subjects experiencing increase from baseline in a single-eye IOP by ≥10 mmHg in either eye at Day 56
timeFrame: Baseline and Day 56
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Celerion
state: Arizona
city: Lincoln
country: United States
facility: Celerion
state: Nebraska
Study officials:
affiliation: Astellas Pharma Global Development
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.