The purpose of this study is to assess the affect of mirabegron on intraocular pressure (IOP) in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
QUADRUPLE
Enrollment
321
oral
oral
Celerion
Tempe, Arizona, United States
Celerion
Lincoln, Nebraska, United States
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
Time frame: Baseline and Day 56
Change from baseline to Day 10 in subject-average IOP
Time frame: Baseline and Day 10
Number of subjects experiencing increase from baseline in a single-eye IOP by ≥6mmHg in either eye at Day 10
Time frame: Baseline and Day 10
Number of subjects experiencing increase from baseline in a single-eye IOP by ≥6mmHg in either eye at Day 56
Time frame: Baseline and Day 56
Number of subjects experiencing increase from baseline in a single-eye IOP by≥10 mmHg in either eye at Day 10
Time frame: Baseline and Day 10
Number of subjects experiencing increase from baseline in a single-eye IOP by ≥10 mmHg in either eye at Day 56
Time frame: Baseline and Day 56
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