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The purpose of this study is to evaluate the microbiological and clinical efficacy of Auriclosene compared to its vehicle for bacterial conjunctivitis. Adults and children one year of age and older with bacterial conjunctivitis in at least one eye may be eligible. Subjects will be randomly assigned to receive either Auriclosene Ophthalmic Solution or Vehicle Ophthalmic Solution.
This is a randomized (1:1) double-masked, vehicle-controlled, multi-center, parallel group study with two treatment arms: Auriclosene Ophthalmic Solution 0.3% ("Auriclosene") and Auriclosene Vehicle ("Vehicle").
Subjects that meet all inclusion/exclusion criteria will be enrolled into the study, randomized and evaluated at 3 visits:
IP will be dosed OU (both eyes) QID for 4 days. Microbiological specimens will be collected from each eye at each visit.
Visual Acuity will be assessed OU at each visit as well as rating of the ocular signs: lid erythema and swelling, bulbar and palpebralconjunctival injection, and conjunctival discharge/exudate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Auriclosene Solution 0.3% | Experimental | Dosed QID for 4 Days |
|
| Auriclosene Vehicle | Placebo Comparator | Dosed QID for 4 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Auriclosene Solution 0.3% | Drug | Ophthalmic solution dispensed as drops onto the eye |
|
| Measure | Description | Time Frame |
|---|---|---|
| Microbiological Success | Eradication of all pre-therapy isolates | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Cure | Resolution of all signs and symptoms | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Resolution of individual ocular signs and symptoms | 5 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David W. Stroman, Ph.D. | NovaBay Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35244 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29602567 | Derived | Lee CS, Lee AY, Akileswaran L, Stroman D, Najafi-Tagol K, Kleiboeker S, Chodosh J, Magaret A, Wald A, Van Gelder RN; BAYnovation Study Group. Determinants of Outcomes of Adenoviral Keratoconjunctivitis. Ophthalmology. 2018 Sep;125(9):1344-1353. doi: 10.1016/j.ophtha.2018.02.016. Epub 2018 Mar 27. |
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| Auriclosene Vehicle | Drug | Ophthalmic Vehicle solution dispensed as drops onto the eye |
|
| Phoenix |
| Arizona |
| 85032 |
| United States |
| Anaheim | California | 92804 | United States |
| Bellflower | California | 90706 | United States |
| Glendale | California | 91204 | United States |
| Huntington Beach | California | 92647 | United States |
| Clearwater | Florida | 33761 | United States |
| Woodstock | Georgia | 30189 | United States |
| Evansville | Indiana | 47714 | United States |
| Newton | Kansas | 67114 | United States |
| Whitehouse Station | New Jersey | 08889 | United States |
| Huntersville | North Carolina | 28078 | United States |
| Winston-Salem | North Carolina | 27101 | United States |
| Cincinnati | Ohio | 45246 | United States |
| Dayton | Ohio | 45432 | United States |
| Corsicana | Texas | 75110 | United States |
| San Antonio | Texas | 78215 | United States |
| Clinton | Utah | 84015 | United States |
| Charlottesville | Virginia | 22902 | United States |
| Midlothian | Virginia | 23113 | United States |
| Spokane | Washington | 99202 | United States |
| ID | Term |
|---|---|
| D003234 | Conjunctivitis, Bacterial |
| D003231 | Conjunctivitis |
| ID | Term |
|---|---|
| D015818 | Eye Infections, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D015817 | Eye Infections |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C560851 | NVC-422 |
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