None listed
Conditions
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.
Interventions
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 compli
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.
Sponsors
The University of New South Wales
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
45 Years to No maximum
Healthy volunteers
Yes
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
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
Outcome results
None listed