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Evaluation of SUMMIT BRUSH in Treatment of Blepharitis

University of Notre Dame · NCT04603222

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
60
US sites recruiting
3
Study start
July 21, 2020
Record last updated
November 27, 2020

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

Dry Eye Disease (DED) is a multifactorial disease that affects \~15-30 million people in the USA alone. It creates an enormous societal and economic burden, decreases productivity in the workplace, and affects the quality of lives of the people affected by this disease. DED is primarily caused by blepharitis, a chronic inflammation of the eyelid margins. If left untreated, blepharitis results in the obstruction and loss of the glands responsible for tear film production. The standard of care is the use of self-administered at home commercially available products, e.g., eyelid foams, gels, and pads. Although these products are helpful, they have limitations. Patients often require expensive in office procedures, e.g., lid debridement with exfoliation devices or more expensive procedures. The scope of this project is to evaluate the effectiveness of a new self-administered disposable ocular brush used in conjunction with the most common eyelid cleanser. The investigators are looking to see if combining the microexfoliation provided by the brush with the eyelid cleanser is more effective at removing the eyelid debris than the cleanser alone.

Being studied: SUMMIT BRUSH; Ocusoft Lid Scrub Original Foaming Eyelid Cleanser

Conditions: Blepharitis

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • Clinical signs and symptoms of blepharitis (Staphylococcal and Demodex).
  • Must exhibit visible collarettes, clear sleeves, and scurfs on the eyelid margins upon Slit Lamp Biomicroscopy.

Exclusion Criteria

  • Hordeolum
  • Chalazion
  • Periorbital cellulitis
  • Allergic eyelid dermatitis.
  • Acute bacterial conjunctivitis
  • Open periorbital wounds.

Recruiting US locations

  • University of Colorado

    Boulder, CO 80303

    Site contact: Mangan Richard, OD · 303-545-2020

  • Michiana Eye Center

    Mishawaka, IN 46545

    Site contact: Kevin Danahey, OD · 574-271-3939 · kadod@aol.com

  • Kentucky Eye Institute

    Lexington, KY 40509

    Site contact: Paul Karpecki, OD · 859-227-7781

Study contacts (from the official record)

  • Giles E Duffield, Ph.D. · 5746311834 · duffield.2@nd.edu
Evaluation of SUMMIT BRUSH in Treatment of Blepharitis (NCT04603222) | Bored Studies