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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Demodex mites

Blepharitis

Condition category

Condition code

Eye

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]

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]

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]

At baseline and after 30 days of daily use of Blephadex™ Eyelid Wipes.

Secondary outcome [1]

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]

At baseline and after 30 days of daily use of Blephadex™ Eyelid Wipes.

Secondary outcome [2]

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]

At baseline and after 30 days of daily use of Blephadex™ Eyelid Wipes.

Secondary outcome [3]

Change in ocular symptoms were measured using the validated questionnaire Ocular Surface Disease Index (OSDI) questionnaire.

Timepoint [3]

At baseline and after 30 days of daily use of Blephadex™ Eyelid Wipes.

Secondary outcome [4]

Change in monocular ocular symptoms of itching was measured using 100mm Visual Analogue Scales..

Timepoint [4]

At baseline and after 30 days of daily use of Blephadex™ Eyelid Wipes.

Secondary outcome [5]

Change in monocular ocular symptoms of dryness was measured using 100mm Visual Analogue Scales.

Timepoint [5]

At baseline and after 30 days of daily use of Blephadex™ Eyelid Wipes.

Secondary outcome [6]

Change in monocular ocular symptoms of overall discomfort was measured using 100mm Visual Analogue Scales.

Timepoint [6]

At baseline and after 30 days of daily use of Blephadex™ Eyelid Wipes.

Secondary outcome [7]

Tear film stability was measured using Non-invasive tear break up time (seconds) with Tearscope Plus.

Timepoint [7]

At baseline and after 30 days of daily use of Blephadex™ Eyelid Wipes.

Secondary outcome [8]

Tear film lipid layer thickness was measured with the LipiView interferometer (nanometres).

Timepoint [8]

At baseline and after 30 days of daily use of Blephadex™ Eyelid Wipes.

Secondary outcome [9]

Tear volume was measured with Phenol red thread test (millimetres).

Timepoint [9]

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

Sex

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

30/11/2016

Date of last participant enrolment

Anticipated

Actual

22/03/2017

Date of last data collection

Anticipated

Actual

18/04/2017

Sample size

Target

20

Accrual to date

Final

20

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

University

Name [1]

The University of New South Wales

Address [1]

UNSW Sydney
High St
Kensington, NSW 2052
Australia

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of New South Wales Human Research Ethics Committee A

Ethics committee address [1]

UNSW Research Ethics & Compliance Support
The University of New South Wales
Sydney NSW 2052 Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

14/07/2016

Ethics approval number [1]

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

Ms Katherine Wong

Address

School of Optometry and Vision Science,
University of New South Wales
Gate 14 Barker St, UNSW
Sydney, NSW 2052
Australia

Country

Australia

Phone

+61293854721

Fax

Email

[email protected]

Contact person for public queries

Name

Katherine Wong

Address

School of Optometry and Vision Science,
University of New South Wales
Gate 14 Barker St, UNSW
Sydney, NSW 2052
Australia

Country

Australia

Phone

+61293854721

Fax

Email

[email protected]

Contact person for scientific queries

Name

Katherine Wong

Address

School of Optometry and Vision Science,
University of New South Wales
Gate 14 Barker St, UNSW
Sydney, NSW 2052
Australia

Country

Australia

Phone

+61293854721

Fax

Email

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	The effect of BlephadexTM Eyelid Wipes on Demodex mites, ocular microbiota, bacterial lipase and comfort: a pilot study.	2019	https://dx.doi.org/10.1016/j.clae.2019.06.001

N.B. These documents automatically identified may not have been verified by the study sponsor.