Clinical Trial: Efficacy of iLid Cleanser (Avenova) Versus Vehicle on Ocular Skin Flora

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Multicenter Randomized, Double-Masked Study Comparing the Efficacy of Novabay iLid Cleanser Versus Vehicle on Ocular Skin Flora

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 Summary:

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.

Sponsor: NovaBay Pharmaceuticals, Inc.

Current Primary Outcome: Microbiological efficacy [ Time Frame: 20 minutes after application of test article ]

Quantitative assessment of numbers of recoverable bacteria before versus after application of test article


Original Primary Outcome: Same as current

Current Secondary Outcome: Ocular Signs [ Time Frame: Assessed on Visit 1(Day 1), Visit 2 (Day 11) and Visit 3 (Day 18) ]

lid erythema, lid swelling, lid crusting and debris on lashes, bulbar and palpebral conjunctival injection, and meibomian gland secretions (after expression)


Original Secondary Outcome: Same as current

Information By: NovaBay Pharmaceuticals, Inc.

Dates:
Date Received: May 26, 2015
Date Started: May 2015
Date Completion: May 2016
Last Updated: May 27, 2015
Last Verified: May 2015