Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT04603222

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

103 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Evaluation of SUMMIT BRUSH in Treatment of Blepharitis

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinical signs and symptoms of blepharitis (Staphylococcal and Demodex)
  • Visible collarettes, clear sleeves, and scurfs on eyelid margins seen with Slit Lamp Biomicroscopy
  • Age 18 years or older
Not Eligible

You will not qualify if you...

  • Active hordeolum (stye)
  • 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

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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

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Research Team

G

Giles E Duffield, Ph.D.

CONTACT

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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