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

NCT02455895 | Unknown

• 1 other identifier: CM-01-14
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

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.

Conditions

Sebaceous Gland Diseases; Blepharitis

Keywords

Blepharitis

Outcome Measures

Primary Outcomes (1)

• Microbiological efficacy

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

  20 minutes after application of test article

Secondary Outcomes (1)

• Ocular Signs

  Assessed on Visit 1(Day 1), Visit 2 (Day 11) and Visit 3 (Day 18)

Study Arms (2)

iLid Cleanser (Avenova)

ACTIVE COMPARATOR

iLid Cleanser - applied 2 times per day for 10 days

Device: iLid Cleanser

iLid Cleanser Vehicle

PLACEBO COMPARATOR

iLid Cleanser Vehicle - applied 2 times per day for 10 days

Device: iLid Cleanser

Interventions

iLid Cleanser DEVICE

Application of iLid Cleanser to reduce bacterial load on the lid and lash margins

Also known as: Avenova

iLid Cleanser (Avenova); iLid Cleanser Vehicle

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NovaBay Pharmaceuticals, Inc.: lead

Study Sites (3)

Ophthalmic Research Consultants of Arizona

Phoenix, Arizona, 85032, United States

RECRUITING

Turner Eye Institute

San Leandro, California, 94577, United States

RECRUITING

James D. Branch, MD

Winston-Salem, North Carolina, 27101, United States

RECRUITING

MeSH Terms

Conditions

Sebaceous Gland Diseases; Blepharitis

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Eyelid Diseases; Eye Diseases

Study Officials

• David W. Stroman, Ph.D.

  NovaBay Pharmaceuticals, Inc.

  STUDY DIRECTOR

Central Study Contacts

David W Stroman, Ph.D.

CONTACT

510-899-8813; dstroman@novabay.com

Katy Najafi-Tagol, MD

CONTACT

415-577-7090; knajafi@novabay.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2015
• First Posted: May 28, 2015
• Study Start: May 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: May 1, 2016
• Last Updated: May 28, 2015

Record last verified: 2015-05

Locations

US (3)