Recruiting

SUMMIT BRUSH

Sponsor:

University of Notre Dame

Code:

NCT04603222

Conditions

Blepharitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

SUMMIT BRUSH

Ocusoft Lid Scrub Original Foaming Eyelid Cleanser

Study Details

Brief 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

Study ID

NCT04603222

Start date

Jul 21, 2020

Status verified date

Oct, 2020

Completion date

Jul 18, 2022

Anticipated

Primary completion date

Oct 24, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

Interventions

SUMMIT BRUSH

SUMMIT BRUSH used for the treatment of blepharitis

Ocusoft Lid Scrub Original Foaming Eyelid Cleanser

treating blepharitis with Ocusoft Lid Scrub Original Foaming Eyelid Cleanser

Primary outcome measure

  • Change in blepharitis severity on eye lid margins [ Time Frame: Initial visit, 2 week follow up, and 4 week follow up ]

Central Contacts and Locations

Central contacts

Giles E Duffield, Ph.D.

5746311834duffield.2@nd.edu

Locations

University of Colorado

Recruiting

Boulder, Colorado, United States, 80303

Contacts

Mangan Richard, OD

303-545-2020

Michiana Eye Center

Recruiting

Mishawaka, Indiana, United States, 46545

Contacts

Marco Minelli

mminelli@mecfps.com

Kentucky Eye Institute

Recruiting

Lexington, Kentucky, United States, 40509

Contacts

Paul Karpecki, OD

859-227-7781

More Information

Sponsor

University of Notre Dame

Last update posted

Nov 27, 2020

Last verified

Oct, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Notre Dame on 2020-11-27.