A Study to Assess Intraocular Pressure and Ocular Safety of the Beta-3 Agonist Mirabegron in Research Subjects

Intraocular Pressure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01284309
• Other study ID #: 178-CL-081
• Status: Completed
• Phase: Phase 1
• First received: January 25, 2011
• Last updated: December 10, 2013
• Start date: November 2010
• Est. completion date: February 2011

Study information

• Verified date: March 2011
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 321
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Intraocular Pressure

Intervention

Drug:
• Mirabegron
oral
• Placebo
oral

Locations

Country	Name	City	State
United States	Celerion	Lincoln	Nebraska
United States	Celerion	Tempe	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to Day 56 in subject-average intraocular pressure (IOP)	Day 56 data will include subjects who discontinue early due to elevated IOP	Baseline and Day 56	Yes
Secondary	Change from baseline to Day 10 in subject-average IOP		Baseline and Day 10	Yes
Secondary	Number of subjects experiencing increase from baseline in a single-eye IOP by =6mmHg in either eye at Day 10		Baseline and Day 10	Yes
Secondary	Number of subjects experiencing increase from baseline in a single-eye IOP by =6mmHg in either eye at Day 56		Baseline and Day 56	Yes
Secondary	Number of subjects experiencing increase from baseline in a single-eye IOP by=10 mmHg in either eye at Day 10		Baseline and Day 10	Yes
Secondary	Number of subjects experiencing increase from baseline in a single-eye IOP by =10 mmHg in either eye at Day 56		Baseline and Day 56	Yes

External Links

•   Link to Results on JAPIC