Recruiting

iLid Cleanser vs. Vehicle

Sponsor:

NovaBay Pharmaceuticals, Inc.

Code:

NCT02455895

Conditions

Sebaceous Gland Diseases

Blepharitis

Eligibility Criteria

Sex: All

Age: 6+

Healthy Volunteers: Not accepted

Interventions

iLid Cleanser

Study Details

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

Study ID

NCT02455895

Start date

May, 2015

Status verified date

May, 2015

Completion date

May, 2016

Anticipated

Primary completion date

Jan, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: iLid Cleanser (Avenova)

iLid Cleanser - applied 2 times per day for 10 days

placebo comparator: iLid Cleanser Vehicle

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

Interventions

iLid Cleanser

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

Primary outcome measure

  • Microbiological efficacy [ Time Frame: 20 minutes after application of test article ]

Central Contacts and Locations

Central contacts

David W Stroman, Ph.D.

510-899-8813dstroman@novabay.com

Katy Najafi-Tagol, MD

415-577-7090knajafi@novabay.com

Locations

Ophthalmic Research Consultants of Arizona

Recruiting

Phoenix, Arizona, United States, 85032

Contacts

Andrea Sarich

602-549-2020sarich.andrea@gmail.com

Principal Investigator:

Arthur Epstein, OD

Turner Eye Institute

Recruiting

San Leandro, California, United States, 94577

Contacts

Erika Chang

800-339-2733echang@turnereye.com

Principal Investigator:

Chirag Patel, MD

James D. Branch, MD

Recruiting

Winston Salem, North Carolina, United States, 27101

Contacts

Elaine Acosta

336-721-4711emaeye@hotmail.com

Principal Investigator:

James Branch, MD

More Information

Sponsor

NovaBay Pharmaceuticals, Inc.

Last update posted

May 28, 2015

Last verified

May, 2015

Keywords

  • Blepharitis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by NovaBay Pharmaceuticals, Inc. on 2015-05-28.