Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04603222 |
| Other study ID # |
SUMMIT BRUSH |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 21, 2020 |
| Est. completion date |
July 18, 2022 |
Study information
| Verified date |
October 2020 |
| Source |
University of Notre Dame |
| Contact |
Giles E Duffield, Ph.D. |
| Phone |
5746311834 |
| Email |
duffield.2[@]nd.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Dry Eye Disease is a multifactorial disease that affects approximately 15-30 million people
in the United States alone. it creates an enormous societal and economic burden, decreases
productivity in our workplace, and significantly affects the quality of lives of the people
affected by this disease. Appoximately 86% of Dry Eye Disease is caused by Blepharitis, a
chronic inflammation of the eyelid margins. If left untreated, Blepharitis results in the
obstruction and eventual loss of the glands responsible for a critical component of tear film
production.
The standard of care in the treatment of Blepharitis is the use of self administered at home
commercially available products such as eyelid foams, gels, and pre moistened pads. These
products contain non abrasive cleansers designed to remove the buildup of biofilm and excess
microorganisms on the lid margin. Although these products are helpful, they do have some
limitations. Many patients still require more expensive in office procedures such as lid
debridement with electro-mechanical exfoliation devices or other even 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 commonly prescribed commercially
available 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 (scurfs, collarettes, and demodex) than the cleanser alone.
Hypothesis: The Summit Ocular Brush used in conjunction with Ocusoft Original lid cleanser is
more effective than the cleanser alone at removing the debris (scurfs, collarettes, and
demodex) from the eyelids in the treatment and management of Blepharitis.
The investigators want to determine if the addition of the ocular brush with the eyelid
cleanser has synergistic effects on reducing the signs and symptoms of Blepharitis and Dry
Eye Disease. They also hope to learn that with this additional step, further and more
expensive procedures could be avoided thereby decreasing the overall economic burden on the
patient and society as a whole.
Recruitment of participants: Dr. Kevin Danahey, Dr. Richard Mangan, and Dr. Paul Karpecki are
the three clinical investigators for this multi-site study. They are all directors of Dry Eye
Clinics and regularly see patients throughout the course of the day. Potential participants
will be identified during routine office visits. Participants will be identified by
subjective symptoms and objective signs of Blepharitis. The SPEED (Standardized Patient
Evaluation of Eye Dryness) Questionnaire will be utilized to identify symptoms and Slit Lamp
Biomicroscopy will be used to identify objective clinical signs of Blepharitis. Once patients
are identified as potential candidates, they will be informed by the investigator that they
are a candidate for a study and asked if they would be interested in participating. A brief
explanation of the study will be given and the patient will be informed that regardless of
which group they are assigned to, they would still be receiving the current standard of care.
The candidates would then be asked to return so that the Investigators may provide informed
consent, thorough written and verbal instructions, HIPPA forms, SPEED questionnaires, and
treatment products. The patients would also have digital photos and video performed with Slit
Lamp Biomicroscopy at that time. These images would only involve the lids and lashes of the
subjects allowing the investigators to protect the identity, gender, and age of the subject.
Study: 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. During each visit,
the subjects will fill out the SPEED questionnaire and digital images and videos will be
taken. The length of each visit should take no longer than 15 minutes. At the conclusion of
the study, subjects in the treatment group will be asked to discontinue the experimental
brush. They would be asked to continue with the current standard of care.
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.
Anterior blepharitis is an ophthalmologic condition characterized by an inflammation of the
eyelid margins. It can be acute or chronic with chronic being the more common form.
Blepharitis is a clinical diagnosis based on irritation of the lid margins with flaking and
crusting of the lashes.
The main treatment for blepharitis is good eyelid hygiene and elimination of triggers that
exacerbate symptoms (Pflugfelder SC, Karpecki PM, Perez VL. Treatment of blepharitis: recent
clinical trials. Ocul Surf. 2014 Oct;12(4):273-84).
Blepharitis is not specific to any group of people. It affects people of all ages,
ethnicities, and gender. It is more common in individuals older than the age of 50. The total
number of cases in the US at any one time is not known. In a 2009 US survey, 37% of patients
seen by an ophthalmologist and 47% of patients seen by an optometrist had signs of
blepharitis.
The exact pathophysiology of blepharitis is not known. The cause is most likely
multifactorial. Causative factors include a combination of chronic low-grade bacterial
infections of the ocular surface, inflammatory skin conditions such as atopy and seborrhea,
and parasitic infestations with Demodex mites.
There are a number of products on the market that aid in reducing the inflammatory and
bacterial load to the lid margin and lashes. However, mechanical debridement (or lid scrubs)
is best at removing debris and the bacterial biofilm that forms in chronic cases. As one
ages, near vision and dexterity worsens. Timely and appropriate lid hygiene then suffers that
may result in lid and ocular infection, as well as vision loss.
The Summit Ocular Brush proposed here should improve the effectiveness of personal home lid
hygiene, even in an aging population. This is what the Investigators wish to study.
The experimental design includes one experimental group and one control group. Subjects will
be divided up such that each clinic collects 10 subjects from each group. This will provide
us with 30 experimental and 30 control subjects and spread evenly between the three separate
clinical locations. Data analysis will be of still images taken from video and photographic
images of the eye lid margins.
Data will be in the form of counts of eyelid debris, specifically 1) scurfs, 2) collarettes,
and 3) demodex. Analysis will be performed by Dr. Duffield and his team at the University of
Notre Dame and will be performed blind. Each subject data set will only be identifiable by a
code, which will not allow for prior knowledge of origins of treatment group. The n=30 sample
size is deemed appropriate for the application of standard statistical methods on continuous
data, specifically parametric t-test or non-parametric Mann-Whitney test. Analysis at the
subgroup level (with 3+ groups), such as incorporation of gender or age fractionation,
parametric ANOVA or nonparametric Kruskal-Wallis tests will be performed on the data,
followed by post-hoc pair wise comparison tests. In all cases, alpha will be set at 0.05,
i.e. p< 0.05 will be seemed significant. The relatively large sample size of 30 subjects in
each main group affords us the opportunity to examine subgroup affects without concern that
the Investigators have insufficient numbers of subjects.
Lid Scrubs are listed at every stage of the treatment algorithm for anterior blepharitis. As
patients age, their ability to perform proper lid scrubs / hygiene declines. Without proper
mechanical debridement of lid and lash flakes, scurfs, collarettes, or mites, this condition
can remain chronic or recalcitrant. Chronic use of topical antibiotics promotes bacterial
resistance and chronic use of steroids puts patients at risk for infection and elevated
intra-ocular pressure. With sound and proper debridement technique using the Summit Ocular
Brush, this should lesson the need for such prescription medication.
Patients will be followed by their doctor's normal standard of care protocol.
The experimental design includes one experimental group and one control group.
Subjects will be divided up such that each clinic collects 10 subjects from each group. This
will provide us with 30 experimental and 30 control subjects and spread evenly between the
three separate clinical locations. Data analysis will be of still images taken from video and
photographic images of the eye lid margins. Data will be in the form of counts of eyelid
debris, specifically 1) scurfs, 2) collarettes, and 3) demodex. Analysis will be performed by
Dr. Duffield and his team at the University of Notre Dame and will be performed blind. Each
subject data set will only be identifiable by a code, which will not allow for prior
knowledge of origins of treatment group. The n=30 sample size is deemed appropriate for the
application of standard statistical methods on continuous data, specifically parametric
t-test or non-parametric Mann-Whitney test. Analysis at the subgroup level (with 3+ groups),
such as incorporation of gender or age fractionation, parametric ANOVA or nonparametric
Kruskal-Wallis tests will be performed on the data, followed by post-hoc pair wise comparison
tests. In all cases, alpha will be set at 0.05, i.e. p< 0.05 will be seemed significant. The
relatively large sample size of 30 subjects in each main group affords us the opportunity to
examine subgroup affects without concern that the Investigators have insufficient numbers of
subjects.
Patients will be followed by their doctor's normal standard of care protocol. Participants
can be both male and female over the age of 18 with clinical signs and symptoms of
Blepharitis (Staphylococcal and Demodex). Participants must exhibit visible collarettes,
clear sleeves, and scurfs on the eyelid margins upon Slit Lamp Biomicroscopy.
Participants both male and female under the age of 18. Patients with any active hordeolum
(stye), chalazion, periorbital cellulitis, or any evidence of allergic eyelid dermatitis.
Participants will also be excluded if they have any active acute bacterial conjunctivitis or
any active open periorbital wounds.
