Actively Recruiting
Evaluation of SUMMIT BRUSH in Treatment of Blepharitis
Led by University of Notre Dame · Updated on 2020-11-27
60
Participants Needed
3
Research Sites
38 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Dry Eye Disease (DED) affects around 15 to 30 million people in the United States and creates significant social and economic challenges. A major cause of DED is blepharitis, a chronic inflammation of the eyelid margins that can lead to obstruction and loss of glands vital for tear production. Traditional care involves self-administered products like eyelid foams, gels, and pads, but these have limitations and some patients require costly in-office procedures. This research aims to evaluate whether a new disposable ocular brush, used with a common eyelid cleanser, is more effective at removing eyelid debris than the cleanser alone. Participants will be divided into two groups: one using the standard treatment of Ocusoft Lid Scrub Original Foaming Eyelid Cleanser once daily, and the other using the same cleanser combined with the experimental Summit Ocular Brush for gentle scrubbing of the eyelids. The brush is disposable and replaced every two weeks. The study includes a treatment period of one month with follow-up visits at two and four weeks. Digital images and videos of the eyelids will be taken to assess debris removal. During the study, participants will complete the SPEED questionnaire and undergo slit lamp exams at each visit to evaluate blepharitis severity. The research team will analyze counts of eyelid debris, including scurfs, collarettes, and demodex mites, using blinded assessment methods. Total participation lasts about one month with two follow-up visits, each lasting no more than 15 minutes, to monitor treatment effects and collect data for comparison between the two groups.
CONDITIONS
Brief Title
Evaluation of SUMMIT BRUSH in Treatment of Blepharitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical signs and symptoms of blepharitis (Staphylococcal and Demodex).
- Visible collarettes, clear sleeves, and scurfs on the eyelid margins upon Slit Lamp Biomicroscopy.
- Age 18 years or older.
- Male or female gender.
You will not qualify if you...
- Presence of hordeolum (stye).
- Presence of chalazion.
- Periorbital cellulitis.
- Allergic eyelid dermatitis.
- Acute bacterial conjunctivitis.
- Open periorbital wounds.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Participants will be identified during routine office visits based on symptoms and eye examination.
Duration - 4 weeks
Participants treat their blepharitis once daily using either the SUMMIT BRUSH with Ocusoft Lid Scrub Original Foaming Eyelid Cleanser or Ocusoft Lid Scrub Original Foaming Eyelid Cleanser alone.
2 follow-up visits at 2 weeks and 4 weeks after starting treatment
Trial Site Locations
Total: 3 locations
1
University of Colorado
Boulder, Colorado, United States, 80303
Actively Recruiting
2
Michiana Eye Center
Mishawaka, Indiana, United States, 46545
Actively Recruiting
3
Kentucky Eye Institute
Lexington, Kentucky, United States, 40509
Actively Recruiting
Research Team
G
Giles E Duffield, Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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