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| ID | Type | Description | Link |
|---|---|---|---|
| BAYnovation | Other Identifier | NovaBay |
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The purpose of this study is to evaluate the clinical and microbiological efficacy and safety of NVC-422 compared to vehicle for adenoviral conjunctivitis. Adults and children one year of age and older with diagnosis of adenoviral conjunctivitis in at least one eye based upon a positive adenovirus test result using the Aden-Detactor Plus kit (Rapid Pathogen Screening, Inc).
Subjects will be randomly assigned to receive either NVC-422 or Vehicle.
This is a randomized (1:1) double-masked, vehicle-controlled, multi-center, parallel group study with two treatment arms: NVC-422 Ophthalmic Solution 0.33% ("NVC-422") and NVC-422 Vehicle ("Vehicle").
Subjects that meet all inclusion/exclusion criteria will be enrolled into the study, randomized and evaluated at 6 visits:
Subjects were dosed OU for 10 days. Specimens were collected OU at each visit for quantitative PCR adenoviral load and molecular typing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NVC-422 Solution, 0.3% | Experimental | Dosed for 10 days |
|
| NVC-422 Vehicle Solution | Placebo Comparator | Dosed for 10 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NVC-422 Solution, 0.3% | Drug | NVC-422 Ophthalmic Solution dropped onto the eye |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sustained Clinical Cure | Day 18 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Stroman, Ph.D. | NovaBay Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glendale | California | 91205 | United States | |||
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| NVC-422 Vehicle Solution | Drug | NVC-422 Vehicle Ophthalmic Solution dropped onto the eye |
|
| Los Angeles |
| California |
| 90048 |
| United States |
| Petaluma | California | 94954 | United States |
| San Diego | California | 92115 | United States |
| Fort Myers | Florida | 33901 | United States |
| Jacksonville Beach | Florida | 32250 | United States |
| Tampa | Florida | 33603 | United States |
| Albany | Georgia | 31701 | United States |
| Kailua | Hawaii | 96734 | United States |
| Glenview | Illinois | 60026 | United States |
| Peoria | Illinois | 61615 | United States |
| Shawnee Mission | Kansas | 66204 | United States |
| Hazard | Kentucky | 41701 | United States |
| Winchester | Massachusetts | 01890 | United States |
| Kansas City | Missouri | 64154 | United States |
| St Louis | Missouri | 63131 | United States |
| Hicksville | New York | 11801 | United States |
| Rockville Centre | New York | 11570 | United States |
| Asheville | North Carolina | 28803 | United States |
| High Point | North Carolina | 27262 | United States |
| Winston-Salem | North Carolina | 27101 | United States |
| Pittsburgh | Pennsylvania | 15206 | United States |
| Charleston | South Carolina | 29414 | United States |
| Spartanburg | South Carolina | 29306 | United States |
| Recife | Pernambuco | 50070-040 | Brazil |
| Rio de Janeiro | Rio de Janeiro | 21941-913 | Brazil |
| Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| Joinville | Santa Catarina | 89201-010 | Brazil |
| São Paulo | São Paulo | 01221-020 | Brazil |
| São Paulo | São Paulo | 04023-062 | Brazil |
| São Paulo | São Paulo | 04502-001 | Brazil |
| Sorocaba | São Paulo | 18031-060 | Brazil |
| Hyderabad | Andhra Pradesh | 500 034 | India |
| Hyderabad | Andhra Pradesh | 500 096 | India |
| Ahmedabad | Gujarat | 380 016 | India |
| Surat | Gujarat | 395 001 | India |
| Bangalore | Karnataka | 560 010 | India |
| Bangalore | Karnataka | 560 054 | India |
| Thiruvanathapuram | Kerala | 695 011 | India |
| Mumbai | Maharashtra | 400 004 | India |
| Mumbai | Maharashtra | 400 020 | India |
| Mumbai | Maharashtra | 400 080 | India |
| Mumbai | Maharashtra | 400 602 | India |
| Daryāganj | New Dehli | 110 002 | India |
| New Dehli | New Dehli | 110 608 | India |
| Bikaner | Rajasthan | 334 001 | India |
| Jaipur | Rajasthan | 302 004 | India |
| Jaipur | Rajasthan | 302 015 | India |
| Chennai | Tamil Nadu | 600 010 | India |
| Salem | Tamil Nadu | 636 004 | India |
| Visakhapatnam | Vishakhapatnam | 530 013 | India |
| Kolkata | West Bengal | 700 073 | India |
| Colombo | 01000 | Sri Lanka |
| Colombo | 11010 | Sri Lanka |
| Colombo | Sri Lanka |
| Kalubowila | 10350 | Sri Lanka |
| Negombo | 11500 | Sri Lanka |
| Nugegoda | 10250 | Sri Lanka |
| ID | Term |
|---|---|
| D000257 | Adenoviridae Infections |
| D003231 | Conjunctivitis |
| ID | Term |
|---|---|
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
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