Evaluation of SUMMIT BRUSH in Treatment of Blepharitis

Conditions

• Blepharitis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• SUMMIT BRUSH — DEVICE
  SUMMIT BRUSH used for the treatment of blepharitis
• Ocusoft Lid Scrub Original Foaming Eyelid Cleanser — OTHER
  treating blepharitis with Ocusoft Lid Scrub Original Foaming Eyelid Cleanser

Study Details

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.

Key Dates

Start date

Jul 21, 2020

Status verified

Oct 2020

Primary completion

Oct 24, 2021

Completion

Jul 18, 2022

Study Design

Enrollment

60 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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

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

• Giles E Duffield, Ph.D.
  5746311834
  [email protected]

Locations (3)

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