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This study is designed to evaluate the effect of Novabay iLid Cleanser, as compared to its Vehicle, on the ocular skin flora.
In the pre-randomization phase, subjects will receive a single application of open-label NovaBay iLid Cleanser.
In the randomization phase of Stages 1 and 2, subjects will self-treat with masked Investigational Product twice daily for ten (10) days.
This is an adaptive design, randomized, double-masked, vehicle-controlled, multicenter, parallel group study with two treatment arms: NovaBay iLid Cleanser ("Cleanser") and Cleanser Vehicle ("Vehicle").
The study will be conducted in two Stages, each preceded by a pre-randomization phase. Randomization of Cleanser:Vehicle will be 1:1 and 2:1 in Stages 1 and 2 respectively.
In the pre-randomization phase for Stages 1 and 2, subjects who meet all inclusion and no exclusion criteria will be evaluated by clinical examination at a single visit prior to having ocular skin specimens taken before and after treatment with open-label Cleanser.
In the randomization phase for both Stages 1 and 2, subjects who meet all inclusion and no exclusion criteria will be randomized and evaluated at three visits:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iLid Cleanser (Avenova) | Active Comparator | iLid Cleanser - applied 2 times per day for 10 days |
|
| iLid Cleanser Vehicle | Placebo Comparator | iLid Cleanser Vehicle - applied 2 times per day for 10 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iLid Cleanser | Device | Application of iLid Cleanser to reduce bacterial load on the lid and lash margins |
|
| Measure | Description | Time Frame |
|---|---|---|
| Microbiological efficacy | Quantitative assessment of numbers of recoverable bacteria before versus after application of test article | 20 minutes after application of test article |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Signs | lid erythema, lid swelling, lid crusting and debris on lashes, bulbar and palpebral conjunctival injection, and meibomian gland secretions (after expression) | Assessed on Visit 1(Day 1), Visit 2 (Day 11) and Visit 3 (Day 18) |
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Inclusion Criteria:
Male or female, of any race, at least 6 years of age.
Must be eligible for a recommendation to use eye lid cleansing/scrubs for:
Must be able to read, understand and sign an informed consent form that has been approved by an Institutional Review Board/Ethics Committee. If subject is less than 18 years of age, the informed consent must be signed and dated by subject's legally authorized representative (parent or guardian). Assent to participate should also be obtained from subjects under 18 years of age if required by local regulation.
Must agree to comply with the visit schedule and other requirements of the study. The parent or guardian must agree to ensure compliance of subjects less than 18 years of age.
Must agree to remove contact lenses, if applicable, for 15 minutes before and after application of the study Investigational Product.
Must agree for the duration of the study to refrain from use of makeup/cosmetic products used around the eye(s) such as eye liner, mascara, and/or shadow, foundation or powder. Use of such products is allowed if the eyelid skin area is avoided.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David W Stroman, Ph.D. | Contact | 510-899-8813 | dstroman@novabay.com | |
| Katy Najafi-Tagol, MD | Contact | 415-577-7090 | knajafi@novabay.com |
| Name | Affiliation | Role |
|---|---|---|
| David W. Stroman, Ph.D. | NovaBay Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ophthalmic Research Consultants of Arizona | Recruiting | Phoenix | Arizona | 85032 | United States |
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| ID | Term |
|---|---|
| D012625 | Sebaceous Gland Diseases |
| D001762 | Blepharitis |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
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| Turner Eye Institute | Recruiting | San Leandro | California | 94577 | United States |
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| James D. Branch, MD | Recruiting | Winston-Salem | North Carolina | 27101 | United States |
|