About this trial
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
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Hordeolum
Chalazion
Periorbital cellulitis
Allergic eyelid dermatitis.
Trial design
Parallel
Treatments tested in this trial
SUMMIT BRUSH
DeviceSUMMIT BRUSH used for the treatment of blepharitis
Ocusoft Lid Scrub Original Foaming Eyelid Cleanser
Other interventiontreating blepharitis with Ocusoft Lid Scrub Original Foaming Eyelid Cleanser
Treatment groups
Trial outcomes
Primary outcomes
Change in blepharitis severity on eye lid margins
Digital photography will be used to asses the eye lid margins pre-treatment, during treatment, and post-treatment. The number of collarettes on the eyelashes will be counted at each visit.
Sponsors and contacts
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