Blepharitis Clinical Trial
Official title:
A Multicenter Randomized, Double-Masked Study Comparing the Efficacy of Novabay iLid Cleanser Versus Vehicle on Ocular Skin Flora
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
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