Evaluation of SUMMIT BRUSH in Treatment of Blepharitis
Recruiting now · Not applicable
Conditions studied: Blepharitis
In brief
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.
Key facts
- Study ID
- NCT04603222
- Run by
- University of Notre Dame
- People needed
- 60
- Starts
- 2020-07-21
- Expected to finish
- 2022-07-18
- Last updated by the study team
- 2020-11-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- Hordeolum
- Chalazion
- Periorbital cellulitis
- Allergic eyelid dermatitis.
- Acute bacterial conjunctivitis
- Open periorbital wounds.
Where it is running
- University of Colorado — Boulder, Colorado, United States (enrolling)
- Michiana Eye Center — Mishawaka, Indiana, United States (enrolling)
- Kentucky Eye Institute — Lexington, Kentucky, United States (enrolling)
Full record on ClinicalTrials.gov
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