NCT02455895

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: NovaBay Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sebaceous Gland Diseases
• Blepharitis

Interventions

Type	Name	Description
DEVICE	iLid Cleanser	Application of iLid Cleanser to reduce bacterial load on the lid and lash margins

Timeline

• Start date: 2015-05-01
• Primary completion: 2016-01-01
• Completion: 2016-05-01
• First posted: 2015-05-28
• Last updated: 2015-05-28

Locations

3 sites across 1 country: United States