Evaluation of SUMMIT BRUSH in Treatment of Blepharitis

ConditionBlepharitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Notre Dame

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Hordeolum

Chalazion

Periorbital cellulitis

Allergic eyelid dermatitis.

Trial design

Design model

Parallel

Treatments tested in this trial

  • SUMMIT BRUSH

    Device

    SUMMIT BRUSH used for the treatment of blepharitis

  • Ocusoft Lid Scrub Original Foaming Eyelid Cleanser

    Other intervention

    treating blepharitis with Ocusoft Lid Scrub Original Foaming Eyelid Cleanser

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Treatment GroupExperimental treatment 2 interventions
Group B: Control GroupActive comparator 1 intervention

Trial outcomes

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.

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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