Evaluating a new brush for treating blepharitis
Evaluation of SUMMIT BRUSH in Treatment of Blepharitis
NA · University of Notre Dame · NCT04603222
This study is testing a new brush combined with a regular eyelid cleanser to see if it helps people with blepharitis feel better and reduce dry eye symptoms.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Notre Dame (other) |
| Locations | 3 sites (Boulder, Colorado and 2 other locations) |
| Trial ID | NCT04603222 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of the SUMMIT BRUSH, a new self-administered disposable ocular brush, in conjunction with a commonly prescribed eyelid cleanser for treating blepharitis, a major cause of Dry Eye Disease. The study aims to determine if this combination is more effective at removing eyelid debris compared to standard treatments. Participants will be assessed for clinical signs and symptoms of blepharitis, and the trial will involve the use of slit lamp biomicroscopy to evaluate treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates are individuals exhibiting clinical signs of blepharitis, such as visible collarettes and scurfs on the eyelid margins.
Not a fit: Patients with conditions like hordeolum, chalazion, or acute bacterial conjunctivitis may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a more effective and convenient treatment option for patients suffering from blepharitis.
How similar studies have performed: While there have been studies on eyelid cleansers, the specific use of the SUMMIT BRUSH in this context is a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Boulder, Colorado and 2 other locations
- University of Colorado — Boulder, Colorado, United States (RECRUITING)
- Michiana Eye Center — Mishawaka, Indiana, United States (RECRUITING)
- Kentucky Eye Institute — Lexington, Kentucky, United States (RECRUITING)
Study contacts
- Principal investigator: Giles E Duffield, Ph.D. — University of Notre Dame
- Study coordinator: Giles E Duffield, Ph.D.
- Email: duffield.2@nd.edu
- Phone: 5746311834
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Blepharitis