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To evaluate the effect of netarsudil (AR-13324) ophthalmic solution on aqueous humor dynamics relative to its placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental | Netarsudil (AR-13324) Ophthalmic Solution |
|
| Placebo | Placebo Comparator | Netarsudil (AR-13324) Ophthalmic Solution Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Netarsudil (AR-13324) Ophthalmic Solution | Drug | Topical ophthalmic solution |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in aqueous humor flow rate measured by non-contact fluorophotometer | Aqueous humor flow rate measured by non-contact fluorophotometer; change from baseline | Day 1 compared to Day 8 |
| Change in outflow facility measured non-invasively by tonography | Outflow facility measured non-invasively by tonography; change from baseline | Day 1 compared to Day 8 |
| Change in episcleral venous pressure measured non-invasively by slit-lamp exam | Episcleral venous pressure measured non-invasively by slit-lamp exam; change from baseline | Day 1 compared toDay 8 |
| Change in visual acuity measured using eye chart | Visual acuity measured using eye chart; change from baseline | Day 1 compared to Day 8 |
| Change in biomicroscopy exam using non-invasive slit-lamp to evaluate cornea, conjunctiva, and anterior chamber of eye | Biomicroscopy exam using non-invasive slit-lamp to evaluate cornea, conjunctiva, and anterior chamber of eye; change from baseline | Day 1 compared to Day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety - Number of participants with adverse events | Number of participants with adverse events as a measure of safety and tolerability | Day 1 compared to Day 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nancy Ramirez | Aerie Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aerie Pharmaceutical | Bedminster | New Jersey | 07921 | United States |
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| Netarsudil (AR-13324) Ophthalmic Solution Placebo |
| Drug |
Ophthalmic solution once a day |
|
| ID | Term |
|---|---|
| C000603944 | netarsudil |
| D009883 | Ophthalmic Solutions |
| ID | Term |
|---|---|
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
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