Evaluation of SUMMIT BRUSH in Treatment of Blepharitis

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
United States
Colorado
University of Colorado
RECRUITING
Boulder
Indiana
Michiana Eye Center
RECRUITING
Mishawaka
Kentucky
Kentucky Eye Institute
RECRUITING
Lexington
Contact Information
Primary
Giles E Duffield, Ph.D.
duffield.2@nd.edu
5746311834
Time Frame
Start Date: 2020-07-21
Estimated Completion Date: 2022-07-18
Participants
Target number of participants: 60
Treatments
Experimental: Treatment Group
Group treating blepharitis with SUMMIT BRUSH and Ocusoft Lid Scrub Original Foaming Eyelid Cleanser once a day
Active_comparator: Control Group
Group treating blepharitis with Ocusoft Lid Scrub Original Foaming Eyelid Cleanser once a day
Related Therapeutic Areas
Sponsors
Leads: University of Notre Dame

This content was sourced from clinicaltrials.gov