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Trial registered on ANZCTR


Registration number
ACTRN12618001368224
Ethics application status
Approved
Date submitted
9/08/2018
Date registered
14/08/2018
Date last updated
14/08/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of Blephadex™ Eyelid Wipes on the ocular microbiota and comfort in normal healthy participants.
Scientific title
The effect of Blephadex™ Eyelid Wipes on ocular microbiota, bacterial lipase and comfort in normal healthy participants
Secondary ID [1] 295774 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Demodex mites 309179 0
Blepharitis 309205 0
Condition category
Condition code
Eye 308054 308054 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Blephadex™ Eyelid Wipe (Lunovus, LLC, Morris, Alabama USA) is a commercially available eyelid cleaner that is self-administered.
Participants were randomly assigned to a single Blephadex™ Eyelid Wipe once daily on either the right or the left eye for 30 days, at the participant's home. A sealed envelope system was employed to notify the participant which eye was allocated to the treatment, whilst the contralateral eye was to receive no treatment and serve as the control.
To check compliance, participants were requested to return any unused wipes to verify that the number of wipes used was consistent with the number of days in the trial.
Intervention code [1] 312102 0
Treatment: Other
Comparator / control treatment
This was a contralateral eye study where one eye was to receive no treatment and serve as the control.
Control group
Active

Outcomes
Primary outcome [1] 307051 0
Demodex mite count. Four lashes were epilated from each eye (one lash from each half of the superior and inferior eyelids) and placed on a glass slide. A coverslip was placed over the lashes and fluorescein was applied to the edge of the coverslip to enhance the appearance of Demodex. Demodex were observed and counted under a light microscope at 40X magnification after 20 minutes.
Timepoint [1] 307051 0
At baseline and after 30 days of daily use of Blephadex™ Eyelid Wipes.
Secondary outcome [1] 350486 0
Bacterial colony count. A swab of the inferior lid margin using a sterile cotton tip was taken and infused in a phosphate-buffered saline solution. The infusion was agitated using a vortex mixer, plated and then cultured. Colony morphology and number of colony forming units (CFU) was recorded, and each type of morphology was speciated by means of Gram staining, catalase and coagulase testing.
Timepoint [1] 350486 0
At baseline and after 30 days of daily use of Blephadex™ Eyelid Wipes.
Secondary outcome [2] 350487 0
Bacterial lipase levels were quantified by growing bacteria isolated from the bacterial culture in liquid media and using the supernatant to perform a glycerol monolaurate assay.
Timepoint [2] 350487 0
At baseline and after 30 days of daily use of Blephadex™ Eyelid Wipes.
Secondary outcome [3] 350491 0
Change in ocular symptoms were measured using the validated questionnaire Ocular Surface Disease Index (OSDI) questionnaire.
Timepoint [3] 350491 0
At baseline and after 30 days of daily use of Blephadex™ Eyelid Wipes.
Secondary outcome [4] 350534 0
Change in monocular ocular symptoms of itching was measured using 100mm Visual Analogue Scales..
Timepoint [4] 350534 0
At baseline and after 30 days of daily use of Blephadex™ Eyelid Wipes.
Secondary outcome [5] 350535 0
Change in monocular ocular symptoms of dryness was measured using 100mm Visual Analogue Scales.
Timepoint [5] 350535 0
At baseline and after 30 days of daily use of Blephadex™ Eyelid Wipes.
Secondary outcome [6] 350536 0
Change in monocular ocular symptoms of overall discomfort was measured using 100mm Visual Analogue Scales.
Timepoint [6] 350536 0
At baseline and after 30 days of daily use of Blephadex™ Eyelid Wipes.
Secondary outcome [7] 350569 0
Tear film stability was measured using Non-invasive tear break up time (seconds) with Tearscope Plus.
Timepoint [7] 350569 0
At baseline and after 30 days of daily use of Blephadex™ Eyelid Wipes.
Secondary outcome [8] 350620 0
Tear film lipid layer thickness was measured with the LipiView interferometer (nanometres).
Timepoint [8] 350620 0
At baseline and after 30 days of daily use of Blephadex™ Eyelid Wipes.
Secondary outcome [9] 350621 0
Tear volume was measured with Phenol red thread test (millimetres).
Timepoint [9] 350621 0
At baseline and after 30 days of daily use of Blephadex™ Eyelid Wipes.

Eligibility
Key inclusion criteria
Able to read and comprehend English and give Informed Consent demonstrated by signing a record of informed consent; 45 years and above; best corrected visual acuity within 2 lines of each other on a logMar chart; willing to use Blephadex Eyelid Wipes and attend two study visits
Minimum age
45 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Active anterior segment infection or disease; commencing ocular medications or systemic medications that might affect tear film or ocular microbiota (including corticosteroids, antibiotics, immunosuppressants, fish oil, flaxseed oil and other omega-3 supplements) less than 3 months prior to the baseline visit or if change in dosage was anticipated during the study; history of ocular surgery in the last 6 months; use of contact lenses within the last 6 months; known pregnancy or lactation; known allergy to tea tree oil, coconut oil or fluorescein dye; heavy makeup users (defined as regular use of eye makeup including mascara, eyeliner, eye shadow and eye creams); history of epilepsy or migraines

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The participants were notified of which eye was allocated to the treatment using a sealed envelope system.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The eye allocated to treatment with the Blephadex Eyelid Wipe was randomly assigned using the web based GraphPad software (https://www.graphpad.com/), to generate the randomisation sequence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Within subject, controlateral eye study
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
This was a pilot study and the sample size was not based on any previous data.
A two-way repeated measures ANOVA was conducted to compare the treated and untreated eyes, and the change in variables between visits. In the presence of a statistically significant interaction, it was appropriate to use paired t-tests to compare change between visits in the treated and untreated groups. all analyses were two-tailed and p < 0.05 was considered statistically significant. Data were log transformed because the distributions were highly skewed. Pearson's correlation test was performed to determine whether any associations exist between Demodex, bacterial lipase, bacterial colony count and lipid layer thickness NITBUT, tear volume or ocular symptoms.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 300365 0
University
Name [1] 300365 0
The University of New South Wales
Address [1] 300365 0
UNSW Sydney
High St
Kensington, NSW 2052
Australia
Country [1] 300365 0
Australia
Primary sponsor type
University
Name
The University of New South Wales
Address
UNSW Sydney
High St
Kensington, NSW 2052
Australia
Country
Australia
Secondary sponsor category [1] 299812 0
None
Name [1] 299812 0
Address [1] 299812 0
Country [1] 299812 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301177 0
The University of New South Wales Human Research Ethics Committee A
Ethics committee address [1] 301177 0
UNSW Research Ethics & Compliance Support
The University of New South Wales
Sydney NSW 2052 Australia
Ethics committee country [1] 301177 0
Australia
Date submitted for ethics approval [1] 301177 0
Approval date [1] 301177 0
14/07/2016
Ethics approval number [1] 301177 0
HC16430

Summary
Brief summary
The purpose of this project was to investigate the effect of daily eyelid cleaning with Blephadex™ Eyelid Wipes on ocular symptoms and signs including Demodex numbers, lipase activity and bacterial culture in normal healthy participants.
The lipid layer is a component of the tear film that is essential to providing tear film stability. Previous research has found increased lipases (enzymes that break down lipids) in the tear film of symptomatic contact lens wearers which were associated with higher dry eye history and symptom scores. Coconut oil which contains about 50% lauric acid has been shown to inhibit bacterial lipase production. Demodex is the most prevalent microscopic ectoparasite found on the human skin, predominantly on the face, and its incidence increases with age. High Demodex counts are also associated with increased Staphylococcus aureus and Staphylococcus epidermis bacteria, as the lipase produced by the bacteria is necessary for Demodex to digest the sebum it feeds on. Ocular discomfort has been also been associated with higher Demodex counts. Concomitantly tea tree oil has been shown to be effective for eliminating ocular Demodex and improving subjective ocular symptoms.
Blephadex™ Eyelid Wipes, contain tea tree oil and coconut oil, however no studies to date have investigated the efficacy of this commercially available product on number of Demodex, Staphyloccocus Aureus count and lipase production.
The aims of this study were to evaluate the effect of using Blephadex™ Eyelid Wipes daily on the (i) units of lipase (ii) number of Demodex (iii) Staphylococcus Aureus count and (iv) Non-Invasive Tear Break-Up Time (NITBUT) and subjective ocular comfort in normal healthy participants.
20 participants were enrolled in this pilot, prospective, single centre, observer masked, within subject design study. Each subject received Blephadex™ Eyelid Wipes and were instructed to use it on one eye only (randomly assigned and unknown to the observer using a sealed envelope system), once daily for a period of 30 days. The contralateral eye received no treatment to be used as the control. At the both the baseline and final visit the same measurements of lipase, Staphylococcus Aureus count, Demodex count, tear film characteristics including NITBUT and subjective ocular comfort were conducted.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86110 0
Ms Katherine Wong
Address 86110 0
School of Optometry and Vision Science,
University of New South Wales
Gate 14 Barker St, UNSW
Sydney, NSW 2052
Australia
Country 86110 0
Australia
Phone 86110 0
+61293854721
Fax 86110 0
Email 86110 0
katherine.y.wong@unsw.edu.au
Contact person for public queries
Name 86111 0
Ms Katherine Wong
Address 86111 0
School of Optometry and Vision Science,
University of New South Wales
Gate 14 Barker St, UNSW
Sydney, NSW 2052
Australia
Country 86111 0
Australia
Phone 86111 0
+61293854721
Fax 86111 0
Email 86111 0
katherine.y.wong@unsw.edu.au
Contact person for scientific queries
Name 86112 0
Ms Katherine Wong
Address 86112 0
School of Optometry and Vision Science,
University of New South Wales
Gate 14 Barker St, UNSW
Sydney, NSW 2052
Australia
Country 86112 0
Australia
Phone 86112 0
+61293854721
Fax 86112 0
Email 86112 0
katherine.y.wong@unsw.edu.au

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary