Evaluation of SUMMIT BRUSH in Treatment of Blepharitis
University of Notre Dame · NCT04603222
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
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