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Recruiting NCT04603222

Evaluation of SUMMIT BRUSH in Treatment of Blepharitis

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Plain-language summary for patients

Trial Parameters

Condition Blepharitis
Sponsor University of Notre Dame
Study Type INTERVENTIONAL
Phase N/A
Enrollment 60
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2020-07-21
Completion 2021-10-24
Interventions
SUMMIT BRUSHOcusoft Lid Scrub Original Foaming Eyelid Cleanser

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Brief 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 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.

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