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This is a double-masked, placebo-controlled study which will determine the action of NCX 470 ophthalmic solution, 0.1% on aqueous humor dynamic parameters in healthy volunteers or subjects with OHT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NCX 470 0.1% | Active Comparator | NCX 470 0.1% - one drop in the randomized eye once a day for 8 days |
|
| Placebo | Placebo Comparator | Artificial tears - one drop in the randomized eye once a day for 8 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NCX 470 | Drug | NCX 470 0.1% vs Placebo |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in AHD | The primary efficacy endpoint is change from baseline in aqueous humor dynamics AHD). AHD is calculated by using well establish techniques which include capturing the following: Aqueous humor flow rates from fluorescein clearance; Outflow facility using constant weigh tonography; Episcleral venous pressure using a venomanometer. The change in ADH will be calculate in normals following 8 (±1) days of dosing of NCX 470 0.1% compared to placebo. | 8 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D009569 | Nitric Oxide |
| D065346 | Lubricant Eye Drops |
| ID | Term |
|---|---|
| D026361 | Reactive Nitrogen Species |
| D005609 | Free Radicals |
| D007287 | Inorganic Chemicals |
| D009589 | Nitrogen Oxides |
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| Placebo | Drug | NCX 0.1% vs Placebo |
|
|
| D017672 |
| Nitrogen Compounds |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D009930 | Organic Chemicals |
| D009883 | Ophthalmic Solutions |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D054327 | Lubricants |
| D020313 | Specialty Uses of Chemicals |