Clinical Trial

Evaluation of SUMMIT BRUSH in Treatment of Blepharitis

Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated November 27, 2020 (before its estimated October 24, 2021 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2020-10-23; most recent amendment 2024-04-28.
Status change: Recruiting → Terminated 2024-04-28
Trial Details
NCT Number NCT04603222
Lead Sponsor University of Notre Dame
Conditions Blepharitis
Enrollment 60 participants
Start Date 2020-07-21
Primary Completion 2021-10-24 (estimated)
Study Completion 2022-07-18 (estimated)
Updated on ClinicalTrials.gov 2020-11-27