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| Name | Class |
|---|---|
| NovaBay Pharmaceuticals, Inc. | INDUSTRY |
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The primary study objectives are: to evaluate (1) the change in ocular discomfort at 30 days and (2) the change in signs and symptoms of ocular surface disease in demodex-positive subjects beginning the use of Avenova.
This is a prospective study of subjects who have been diagnosed with bilateral demodex blepharitis. Qualified symptomatic eyes will be randomized and monitored for 30 days; one eye will undergo Avenova treatment twice daily and one eye will not undergo any study treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Eye | Experimental | One eye will be treated with Avenova; the other eye will not be treated. The investigator is masked as to which eye is receiving Avenova product. |
|
| Non-Treatment Eye | No Intervention | One eye will be treated with Avenova; the other eye will not will be treated. The investigator is masked as to which eye is receiving Avenova product. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avenova Lid Cleanser | Device | Avenova lid cleanser is an FDA-cleared saline solution preserved with 0.01% pure hypochlorous acid. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Severity of Markers of Inflammation | Clinical parameters include prevalence of demodex mites. | 30 days |
| Change in Severity of Markers of Inflammation | Clinical exam parameters include prevalence of tear film break up time. | 30 days |
| Change in Severity of Markers of Inflammation | Clinical exam parameters include corneal and conjunctival staining. | 30 days |
| Change in Severity of Markers of Inflammation | Clinical parameters include evaluation of meibomian gland including evaluation of lipid layer thickness.. | 30 days |
| Change in Severity of Markers of Inflammation using tear osmolarity. | Clinical parameters include tear osmolarity. | 30 days |
| Change in Severity of Markers of Inflammation | Clinical parameters include tear ferning patterns. | 30 days |
| Change in Severity of Markers of Inflammation | Clinical parameters include meibomian gland evaluation | 30 days |
| Change in Ocular Discomfort | Change in ocular discomfort based on scores from Eyelid Inflammation questionnaire. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahmad M Fahmy, OD | Minnesota Eye Consultants | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minnesota eye Consultants, PA | Bloomington | Minnesota | 55431 | United States |
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| ID | Term |
|---|---|
| D001762 | Blepharitis |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
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| 30 days |
| Change in Ocular Discomfort | Change in ocular discomfort based on scores from Ocular Surface Disease Index questionnaire. Scored on a scale of 0-100, with higher scores indicating greater disability. | 30 days |