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Evaluation of SUMMIT BRUSH in Treatment of Blepharitis

NCT04603222 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-11-27

No results posted yet for this study

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.

Conditions

  • Blepharitis

Interventions

DEVICE

SUMMIT BRUSH

SUMMIT BRUSH used for the treatment of blepharitis

OTHER

Ocusoft Lid Scrub Original Foaming Eyelid Cleanser

treating blepharitis with Ocusoft Lid Scrub Original Foaming Eyelid Cleanser

Sponsors & Collaborators

  • University of Notre Dame

    lead OTHER

Principal Investigators

  • Giles E Duffield, Ph.D. · University of Notre Dame

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-21
Primary Completion
2021-10-24
Completion
2022-07-18
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04603222 on ClinicalTrials.gov