Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 2:03 PM
Ignite Modification Date:
2025-12-24 @ 2:03 PM
NCT ID:
NCT02455895
Brief Summary:
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.
Detailed Description:
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:
NCT02455895
Study Brief:
Protocol Section:
NCT02455895