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: * Visit 1: Screening, Day 1 * Visit 2: Day 11 (+2) End of Treatment (EOT) * Visit 3: Day 18 (±2) Post Treatment Evaluation/Exit Subjects will have ocular skin specimens taken at Visit 1, Day 1. The specimens will be collected before and 20 minutes after the first application of the study Investigational Product performed by study personnel.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
100
Application of iLid Cleanser to reduce bacterial load on the lid and lash margins
Ophthalmic Research Consultants of Arizona
Phoenix, Arizona, United States
RECRUITINGTurner Eye Institute
San Leandro, California, United States
RECRUITINGJames D. Branch, MD
Winston-Salem, North Carolina, United States
RECRUITINGMicrobiological efficacy
Quantitative assessment of numbers of recoverable bacteria before versus after application of test article
Time frame: 20 minutes after application of test article
Ocular Signs
lid erythema, lid swelling, lid crusting and debris on lashes, bulbar and palpebral conjunctival injection, and meibomian gland secretions (after expression)
Time frame: Assessed on Visit 1(Day 1), Visit 2 (Day 11) and Visit 3 (Day 18)
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