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



Status:Recruiting
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:6 - Any
Updated:4/2/2016
Start Date:May 2015
End Date:May 2016
Contact:David W Stroman, Ph.D.
Email:dstroman@novabay.com
Phone:510-899-8813

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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.

Inclusion Criteria:

- Male or female, of any race, at least 6 years of age.

- Must be eligible for a recommendation to use eye lid cleansing/scrubs for:

- Signs of acute or chronic blepharitis, such as eye lid debris (sleeves,
collorates, flakes, crusting) requiring eye lid cleansing/scrubs, and/or

- Signs consistent with mild, moderate, or severe meibomian gland disease (MGD)
such as dilated and blocked glands with inspissated secretions sluggish or
stagnant upon expression.

- Must be able to read, understand and sign an informed consent form that has been
approved by an Institutional Review Board/Ethics Committee. If subject is less than
18 years of age, the informed consent must be signed and dated by subject's legally
authorized representative (parent or guardian). Assent to participate should also be
obtained from subjects under 18 years of age if required by local regulation.

- Must agree to comply with the visit schedule and other requirements of the study. The
parent or guardian must agree to ensure compliance of subjects less than 18 years of
age.

- Must agree to remove contact lenses, if applicable, for 15 minutes before and after
application of the study Investigational Product.

- Must agree for the duration of the study to refrain from use of makeup/cosmetic
products used around the eye(s) such as eye liner, mascara, and/or shadow, foundation
or powder. Use of such products is allowed if the eyelid skin area is avoided.

Exclusion Criteria:

- Presence of signs and symptoms of bacterial or allergic conjunctivitis or allergic
dermatitis at the Day 1 Visit.

- Suspected fungal, viral, Chlamydia or Acanthamoeba infection based on clinical
diagnosis.

- Visual acuity not correctable to 1.0 LogMAR or better (equivalent to Snellen 20/200)
in either eye using either a Snellen or ETDRS chart.

- Use of any topical ocular medications including tear substitutes during study
participation.

- Use of any preserved or non-preserved glaucoma medications during the 14 days prior
to Visit 1 and anticipated use during study participation.

- Presence of nasolacrimal duct obstruction.

- Presence of a punctal plug in either eye.

- Any systemic or ocular disease or disorder, complicating factors or structural
abnormality that would negatively affect the conduct or outcome of the study.

- Presence of active inflammation and/or active structural change in the cornea, iris
or anterior chamber at the Day 1 visit.

- Use of any topical ocular or oral antimicrobial agent within the 3 days prior to Day
1 visit.

- Use of topical ocular corticosteroids or non-steroidal topical ocular
anti-inflammatories (NSAIDs), within 3 days prior to study entry and during the
trial.

- Use of RESTASIS® (Cyclosporine Ophthalmic Emulsion) 0.05%) in either eye during the
trial.

- Any current immunosuppressive disorder (e.g., HIV positive), or use of
immunosuppressive therapy (including chemotherapy).

- Participation in any other investigational clinical study within 30 days prior to
study enrollment.

- Any subject who is on staff at the investigational site or is a family member of
staff personnel.

- Additionally, the Investigator or Medical Monitor may declare any subject ineligible
for a sound medical reason.
We found this trial at
3
sites
San Leandro, California 94577
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Winston Salem, North Carolina 27101
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Winston Salem, NC
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