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The objective of this clinical study is to evaluate the safety and efficacy of NCX 470 Ophthalmic Solution in lowering intraocular pressure (IOP) in subjecs with ocular hypertension or open-angle glaucoma. Subjects will be randomized in a 1:1 ratio to NCX 470 0.1% or to latanoprost 0.005% to be administered to both eyes once daily in the evening for up to 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NCX 470 0.1% | Experimental | NCX 470 Ophthalmic Solution, 0.1% dosed once daily to both eyes |
|
| Latanoprost 0.005% | Active Comparator | Latanoprost Ophthalmic Solution, 0.005% dosed once daily to both eyes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NCX 470 0.1% | Drug | NCX 470 Ophthalmic Solution, 0.1% |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline IOP | Mean IOP change from time-matched baseline at 8AM and 4PM time points at the Week 2, Week 6 and Month 3 Visits in the study eye | Up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in diurnal IOP | Mean diurnal IOP change from baseline at the Week 2, Week 6 and Month 3 Visits in the study eye | Up to 3 months |
| Frequency and incidence of treatment-emergent adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicox Ophthalmics | Nicox Ophthalmics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nicox Clinical Site | Dothan | Alabama | 36301 | United States | ||
| Nicox Clinical Site |
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double-masked
| Latanoprost 0.005% | Drug | Latanoprost Ophthalmic Solution, 0.005% |
|
|
Number and percentage of subjects with ocular and non-ocular treatment-emergent adverse events
| 12 months |
| Rate of discontinuation | Percentage of subjects in each treatment group who discontinue study participation | 12 months |
| Chandler |
| Arizona |
| 85224 |
| United States |
| Nicox Clinical Site | Phoenix | Arizona | 85003 | United States |
| Nicox Clinical Site | Burbank | California | 91505 | United States |
| Nicox Clinical Site | Garden Grove | California | 92843 | United States |
| Nicox Clinical Site | Huntington Beach | California | 92647 | United States |
| Nicox Clinical Site | La Jolla | California | 92037 | United States |
| Nicox Clinical Site | Murrieta | California | 92562 | United States |
| Nicox Clinical Site | Newport Beach | California | 92663 | United States |
| Nicox Clinical Site | Pasadena | California | 91107 | United States |
| Nicox Clinical Site | Petaluma | California | 94954 | United States |
| Nicox Clinical Site | Redlands | California | 92373 | United States |
| Nicox Clinical Site | San Francisco | California | 94115 | United States |
| Nicox Clinical Site | Danbury | Connecticut | 06810 | United States |
| Nicox Clinical Site | Boynton Beach | Florida | 33437 | United States |
| Nicox Clinical Site | Delray Beach | Florida | 33484 | United States |
| Nicox Clinical Site | Fort Lauderdale | Florida | 33309 | United States |
| Nicox Clinical Site | Fort Myers | Florida | 33901 | United States |
| Nicox Clinical Site | Jacksonville | Florida | 32256 | United States |
| Nicox Clinical Site | Jupiter | Florida | 33477 | United States |
| Nicox Clinical Site | Lakeland | Florida | 33805 | United States |
| Nicox Clinical Site | Largo | Florida | 33770 | United States |
| Nicox Clinical Site | Mt. Dora | Florida | 32757 | United States |
| Nicox Clinical Site | Venice | Florida | 34285 | United States |
| Nicox Clinical Site | Morrow | Georgia | 30260 | United States |
| Nicox Clinical Site | Roswell | Georgia | 30076 | United States |
| Nicox Clinical Site | Peoria | Illinois | 61615 | United States |
| Nicox Clinical Site | Rock Island | Illinois | 61201 | United States |
| Nicox Clinical Site | Indianapolis | Indiana | 46202 | United States |
| Nicox Clinical Site | Bangor | Maine | 04401 | United States |
| Nicox Clinical Site | Boston | Massachusetts | 02114 | United States |
| Nicox Clinical Site | Lancaster | Massachusetts | 01523 | United States |
| Nicox Clinical Site | Grand Rapids | Michigan | 49546 | United States |
| Nicox Clinical Site | Chaska | Minnesota | 55318 | United States |
| Nicox Clinical Site | Kansas City | Missouri | 64111 | United States |
| Nicox Clinical Site | St Louis | Missouri | 63128 | United States |
| Nicox Clinical Site | Clifton Park | New York | 12065 | United States |
| Nicox Clinical Site | The Bronx | New York | 10467 | United States |
| Nicox Clinical Site | Troy | New York | 12180 | United States |
| Nicox Clinical Site | Asheville | North Carolina | 28803 | United States |
| Nicox Clinical Site | Winston-Salem | North Carolina | 27101 | United States |
| Nicox Clinical Site | Fargo | North Dakota | 58103 | United States |
| Nicox Clinical Site | Cincinnati | Ohio | 45236 | United States |
| Nicox Clinical Site | Cincinnati | Ohio | 45242 | United States |
| Nicox Clinical Site | Eugene | Oregon | 97401 | United States |
| Nicox Clinical Site | Cranberry Township | Pennsylvania | 16066 | United States |
| Nicox Clinical Site | Kingston | Pennsylvania | 18704 | United States |
| Nicox Clinical Site | Memphis | Tennessee | 38119 | United States |
| Nicox Clinical Site | Memphis | Tennessee | 38120 | United States |
| Nicox Clinical Site | Austin | Texas | 78731 | United States |
| Nicox Clinical Site | El Paso | Texas | 79922 | United States |
| Nicox Clinical Site | Houston | Texas | 77008 | United States |
| Nicox Clinical Site | Houston | Texas | 77025 | United States |
| Nicox Clinical Site | Mission | Texas | 78572 | United States |
| Nicox Clinical Site | San Antonio | Texas | 78212 | United States |
| Nicox Clinical Site | San Antonio | Texas | 78229 | United States |
| Nicox Clinical Site | San Antonio | Texas | 78238 | United States |
| Nicox Clinical Site | Sugar Land | Texas | 77479 | United States |
| Nicox Clinical Site | St. George | Utah | 84790 | United States |
| Nicox Clinical Site | Falls Church | Virginia | 22042 | United States |
| Nicox Clinical Site | Bellevue | Washington | 98004 | United States |
| Nicox Clinical Site | Seattle | Washington | 98104 | United States |
| Nicox Clinical Site | Seattle | Washington | 98125 | United States |
| Nicox Clinical Site | Lanzhou | Gansu | 730030 | China |
| Nicox Clinical Site | Shantou | Guangdong | 515401 | China |
| Nicox Clinical Site | Harbin | Heilongjiang | 150086 | China |
| Nicox Clinical Site | Zhengzhou | Henan | 450003 | China |
| Nicox Clinical Site | Zhengzhou | Henan | 450052 | China |
| Nicox Clinical Site | Wuhan | Hubei | 430060 | China |
| Nicox Clinical Site | Yichang | Hubei | 443003 | China |
| Nicox Clinical Site | Changsha | Hunan | 410011 | China |
| Nicox Clinical Site | Changsha | Huna | 410015 | China |
| Nicox Clinical Site | Nanchang | Jiangxi | 330006 | China |
| Nicox Clinical Site | Changchun | Jilin | 130021 | China |
| Nicox Clinical Site | Dalian | Liaoning | 116091 | China |
| Nicox Clinical Site | Xi'an | Shaanxi | 710004 | China |
| Nicox Clinical Site | Jinan | Shandong | 250002 | China |
| Nicox Clinical Site | Qingdao | Shandong | 266071 | China |
| Nicox Clinical Site | Chengdu | Sichuan | 610041 | China |
| Nicox Clinical Site | Wenzhou | Xhejiang | 325027 | China |
| Nicox Clinical Site | Beijing | 100005 | China |
| Nicox Clinical Site | Beijing | 100191 | China |
| Nicox Clinical Site | Chongqing | 400020 | China |
| Nicox Clinical Site | Shanghai | 200011 | China |
| Nicox Clinical Site | Shanghai | 200031 | China |
| Nicox Clinical Site | Shanghai | 200040 | China |
| Nicox Clinical Site | Tianjing | 300020 | China |
| Nicox Clinical Site | Tianjing | 300384 | China |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000077338 | Latanoprost |
| ID | Term |
|---|---|
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
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