RecruitingNot ApplicableNCT04603222

Evaluation of SUMMIT BRUSH in Treatment of Blepharitis


Sponsor

University of Notre Dame

Enrollment

60 participants

Start Date

Jul 21, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • 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 Criteria6

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

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Interventions

DEVICESUMMIT BRUSH

SUMMIT BRUSH used for the treatment of blepharitis

OTHEROcusoft Lid Scrub Original Foaming Eyelid Cleanser

treating blepharitis with Ocusoft Lid Scrub Original Foaming Eyelid Cleanser


Locations(3)

University of Colorado

Boulder, Colorado, United States

Michiana Eye Center

Mishawaka, Indiana, United States

Kentucky Eye Institute

Lexington, Kentucky, United States

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NCT04603222


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