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Effect of eyelid cleansing on eye surface inflammation

Effect of eyelid cleansing on ocular surface inflammation in normal eyes and in blepharitis

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616000545460
Enrollment
50
Registered
2016-04-28
Start date
2016-05-25
Completion date
2016-09-01
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Blepharitis (eyelid inflammation) is a common chronic eyelid condition associated with inflamed eyelid margins and it leads to symptoms of persistent eye irritation and visual disturbance in affected individuals. Eyelid cleansing to free the eyelashes and eyelid margins from crusts, debris and significant bacterial load, is considered fundamental in the management of blepharitis to minimise eyelid inflammation. Modern, sterile, commercial products, designed specifically for use in this condition are available, but the traditional therapy of baby shampoo continues to be recommended in some centres, despite suggestions in the literature of its potentially pro-inflammatory nature around the delicate structures of the eye, the ocular surface and the preocular tear film. Using a sensitive technique by which ocular surface inflammation can be quantified from impression cytology samples collected in the clinic specific inflammatory marker levels will be quantified, to determine whether the clinician recommended therapies affect the level of ocular surface inflammation.

Interventions

Commercial lid scrub (Sterilid by Theratears - Company Serial 78459728) As per manufacturers instructions, one pump as foam applied by participant to closed eyelids with fingertips, twice daily (in the morning and at night) for 4 weeks, at participant's home. The product will be stripped of packaging and brand and labelled with "R" for right eye or "L" for left eye. Returned product at the end of the trial will be weighed as a measure of compliance

Sponsors

The University of Auckland
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Aged 16 years or over Blepharitis patients: With symptoms of dry eye and/or a previous diagnosis of blepharitis and/or clinical signs of blepharitis on examination Healthy volunteers: Without symptoms of dry eye, without a diagnosis of blepharitis, and without clinical signs of blepharitis on examination Ability to adhere to the study schedule of product application and attendance for evaluation

Exclusion criteria

Contact lens wearers who are unable to cease contact lens wear for the duration of the experiment. Individuals who declare or are noted on examination to have previously undergone eye surgery, or experienced trauma or disease affecting the anterior eye. Individuals who are not willing or able to complete the consent process Individuals with a known allergy to any components in the study products

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026