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Trial registered on ANZCTR


Registration number
ACTRN12616000545460
Ethics application status
Approved
Date submitted
26/04/2016
Date registered
28/04/2016
Date last updated
13/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of eyelid cleansing on eye surface inflammation
Scientific title
Effect of eyelid cleansing on ocular surface inflammation in normal eyes and in blepharitis
Secondary ID [1] 289084 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Blepharitis
 298537 0
Dry eye disease 298538 0
Condition category
Condition code
Eye 298623 298623 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 294592 0
Treatment: Other
Comparator / control treatment
Diluted 1:10 Baby Shampoo (Johnson's Baby - Company serial 74458492)
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. Participants and those collecting clinical data will be masked as to the randomisation of the product to right and left eyes.

The effect of the products will further be compared between participants with signs of blepharitis and individuals with normal eyes, to determine whether a difference in baseline inflammation makes a difference to the outcomes.
Control group
Active

Outcomes
Primary outcome [1] 298114 0
Clinical assessment of ocular surface inflammation and damage via objective bulbar hyperaemia assessment and ocular surface staining (Oculus Keratograph 5M with and without instilled sodium fluorescein and lissamine green)
Timepoint [1] 298114 0
At baseline and 4 weeks after commencement of intervention
Primary outcome [2] 298115 0
Ocular inflammation and surface damage as assessed in the laboratory (by impression cytology with the EYEPRIM device for inflammatory markers, IL-6 and MMP-9)
Timepoint [2] 298115 0
At baseline and 4 weeks after commencement of intervention
Secondary outcome [1] 323215 0
Ocular symptoms by validated questionnaires; Ocular Surface Disease Index (OSDI) and Standard Patient Evaluation of Eye Dryness (SPEED)
Timepoint [1] 323215 0
At baseline and 4 weeks after commencement of intervention

Eligibility
Key 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
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

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)
Participants are given unique ID numbers and given identical foam applicators with no branding or labelling, marked as L for left eye, and R for right eye.
Each participant is randomly allocated baby shampoo or commercial lid cleanser for their left eye, and the other is given to the right eye. This allocation is concealed to both the investigator collecting clinical data and the participant, by having numbered containers (1 or 2). All containers of the same number have the same contents and are numbered by an independent third party. They are then marked as L or R in alternating order so there are L and R markings on both 1 and 2 containers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random.org is used which generates truly random numbers using atmospheric noise. Either 1 or 2 is generated for the left eye. The appropriately marked container is selected and the other eye is given the other number.

Eg. If "1" is generated by random.org for the participant's left eye, the container labelled "L" from the "1" group is given. It is unknown if the 1 group is baby shampoo or commercial cleanser. The right eye is then given the container labelled "R" from the "2" group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Paired eye evaluation
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/05/2016
Actual
25/05/2016
Date of last participant enrolment
Anticipated
15/08/2016
Actual
1/09/2016
Date of last data collection
Anticipated
Actual
29/09/2016
Sample size
Target
50
Accrual to date
Final
50
Recruitment outside Australia
Country [1] 7841 0
New Zealand
State/province [1] 7841 0
Auckland

Funding & Sponsors
Funding source category [1] 293461 0
University
Name [1] 293461 0
The University of Auckland
Country [1] 293461 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
Private Bag 92019
Auckland
1142
Country
New Zealand
Secondary sponsor category [1] 292283 0
None
Name [1] 292283 0
None
Address [1] 292283 0
None
Country [1] 292283 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294903 0
University of Auckland Human Participants Ethics Committee
Ethics committee address [1] 294903 0
Private Bag 92019
Auckland
1142
Ethics committee country [1] 294903 0
New Zealand
Date submitted for ethics approval [1] 294903 0
22/04/2016
Approval date [1] 294903 0
26/04/2016
Ethics approval number [1] 294903 0
UAHPEC 011255

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65406 0
A/Prof Jennifer P Craig
Address 65406 0
Department of Ophthalmology
The University of Auckland
Private Bag 92019
Auckland
1142
Country 65406 0
New Zealand
Phone 65406 0
+6499238173
Fax 65406 0
+6493677173
Email 65406 0
[email protected]
Contact person for public queries
Name 65407 0
Jennifer P Craig
Address 65407 0
Department of Ophthalmology
The University of Auckland
Private Bag 92019
Auckland
1142
Country 65407 0
New Zealand
Phone 65407 0
+6499238173
Fax 65407 0
+6493677173
Email 65407 0
[email protected]
Contact person for scientific queries
Name 65408 0
Jennifer P Craig
Address 65408 0
Department of Ophthalmology
The University of Auckland
Private Bag 92019
Auckland
1142
Country 65408 0
New Zealand
Phone 65408 0
+6499238173
Fax 65408 0
+6493677173
Email 65408 0
[email protected]

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