Evaluation of SUMMIT BRUSH in Treatment of Blepharitis

NCT04603222 | Recruiting FDA Device

• 1 other identifier: SUMMIT BRUSH
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• Change in blepharitis severity on eye lid margins

  Digital photography will be used to asses the eye lid margins pre-treatment, during treatment, and post-treatment. The number of collarettes on the eyelashes will be counted at each visit.

  Initial visit, 2 week follow up, and 4 week follow up

Study Arms (2)

Treatment Group

EXPERIMENTAL

Group treating blepharitis with SUMMIT BRUSH and Ocusoft Lid Scrub Original Foaming Eyelid Cleanser once a day

Device: SUMMIT BRUSH; Other: Ocusoft Lid Scrub Original Foaming Eyelid Cleanser

Control Group

ACTIVE COMPARATOR

Group treating blepharitis with Ocusoft Lid Scrub Original Foaming Eyelid Cleanser once a day

Other: Ocusoft Lid Scrub Original Foaming Eyelid Cleanser

Interventions

SUMMIT BRUSH DEVICE

SUMMIT BRUSH used for the treatment of blepharitis

Treatment Group

Ocusoft Lid Scrub Original Foaming Eyelid Cleanser OTHER

treating blepharitis with Ocusoft Lid Scrub Original Foaming Eyelid Cleanser

Control Group; Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Hordeolum
• Chalazion
• Periorbital cellulitis
• Allergic eyelid dermatitis.
• Acute bacterial conjunctivitis
• Open periorbital wounds.

Sponsors & Collaborators

• University of Notre Dame: lead

Study Sites (3)

University of Colorado

Boulder, Colorado, 80303, United States

RECRUITING

Michiana Eye Center

Mishawaka, Indiana, 46545, United States

RECRUITING

Kentucky Eye Institute

Lexington, Kentucky, 40509, United States

RECRUITING

MeSH Terms

Conditions

Blepharitis

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Study Officials

• Giles E Duffield, Ph.D.

  University of Notre Dame

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giles E Duffield, Ph.D.

CONTACT

5746311834; duffield.2@nd.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All SPEED scores and digital images would then be de-identified to avoid any bias by the principal investigator and his research staff. These scores and images would be uploaded and sent electronically via encrypted password protected file to Giles Duffield, PhD. for interpretation and statistical analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This multi-site study will involve 60 subjects. Each site will have 20 participants. Each site will divide participants into two groups of 10. The control group will receive the standard of care. The standard of care would be Ocusoft Lid Scrub Original Foaming Eyelid Cleanser to be used once per day. The treatment group would receive the same treatment as the control group with the addition of the experimental disposable ocular brush. The foam will be applied to the brush and the subjects will gently provide a scrubbing action to the eyelids while keeping the eyelids closed. They will also be instructed to perform treatment once per day and to dispose of the brush after two weeks and replace it with a new brush. Each participant will be asked to return to their respective site for two follow up visits. The first visit will take place at two weeks commencing treatment and the final visit will take place two weeks later for a total treatment duration of one month.

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: October 26, 2020
• Study Start: July 21, 2020
• Primary Completion: October 24, 2021
• Study Completion: July 18, 2022
• Last Updated: November 27, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)