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The purpose of this study is to assess the affect of mirabegron on intraocular pressure (IOP) in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mirabegron | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mirabegron | Drug | oral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to Day 10 in subject-average IOP | Baseline and Day 10 | |
| Number of subjects experiencing increase from baseline in a single-eye IOP by ≥6mmHg in either eye at Day 10 | Baseline and Day 10 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Global Development | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Tempe | Arizona | 85283 | United States | ||
| Celerion |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23586728 | Derived | 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. |
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| ID | Term |
|---|---|
| C520025 | mirabegron |
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| Placebo |
| Drug |
oral |
|
| Number of subjects experiencing increase from baseline in a single-eye IOP by ≥6mmHg in either eye at Day 56 | 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 | 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 | Baseline and Day 56 |
| Lincoln |
| Nebraska |
| 68502 |
| United States |