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Trial registered on ANZCTR


Registration number
ACTRN12612000703808
Ethics application status
Approved
Date submitted
29/06/2012
Date registered
2/07/2012
Date last updated
13/05/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
The age-related changes of the meibomian glands in healthy participants
Scientific title
A cross-sectional cohort to assess the age-related changes to the function and morphology of the meibomian glands and the association of these changes to symptomatology in healthy people aged between 25 and less than 65 years of age
Secondary ID [1] 280756 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Meibomian gland dysfunction 286810 0
Dry eye 286811 0
Condition category
Condition code
Eye 287122 287122 0 0
Normal eye development and function

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a cross-sectional cohort study where approximately 200 participants will be recruited, aged from 25 years to less than 65 years of age. Participants will be seen for one visit only (baseline).

This visit will involve completing standardised questionnaires, examination with a slit-lamp biomicroscope (a specialised microscope for viewing the eye) and the collection of ocular samples iincluding tears, meibum (an oily substance found in the glands of the eye lids) and an ocular swab of the lower eye lid.
Intervention code [1] 285185 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287442 0
Meibum analysis: Meibum will be expressed from the lower eye lids of both eyes and collected with a spatula. Meibum samples will be analysed for their lipid profile using mass spectrometry
Timepoint [1] 287442 0
Baseline visit
Secondary outcome [1] 298155 0
Tear analysis: Tears will be collected non-invasively from the right eye using a glass microcapillary tube placed at the outer canthus. Tear samples will be analysed for inflammatory mediators using Bioplex arrays
Timepoint [1] 298155 0
Baseline visit
Secondary outcome [2] 298156 0
Ocular swab analysis: A swab will be taken from left eye lower lid and analysed for the presence of of microbes using standard microbiological procedures
Timepoint [2] 298156 0
Baseline visit
Secondary outcome [3] 298157 0
Standardised questionnaires: Three standardised questionnaires (ocular surface disease index, the dry eye questionnaire and the McMonies questionnaire) will be used to categorise participants into those with dry eye and those without dry eye.
Timepoint [3] 298157 0
Baseline visit
Secondary outcome [4] 298170 0
Standardised questionnaire: The Victorian Cancer Council food frequency questionnaire will be used to determine whether diet influences meibomian gland dysfunction
Timepoint [4] 298170 0
Baseline visit

Eligibility
Key inclusion criteria
Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent
Be aged between 25 and less than 65 years old, male or female
Have ocular health findings considered to be “normal”
Minimum age
25 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any pre-existing ocular irritation, injury or condition (including infection or disease) of the cornea, conjunctiva or eyelids (excluding dry eye).
Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, androgen deficiency and auto immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjögrens syndrome, acne rosacea and systemic lupus erythematosus. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants.
Concurrent punctal occlusion
Use of or a need for concurrent category S4 and above ocular medication at enrolment and/or during the clinical trial.
Use of or a need for any systemic medication or topical medications which may alter normal ocular findings / are known to affect a participant’s ocular health / physiology either in an adverse or beneficial manner at enrolment and/or during the clinical trial e.g. hormone replacement therapy or anti-androgen therapy.
NB: Systemic antihistamines are allowed on an “as needed basis”, provided they are not used prophylactically during the trial and at least 24 hours before the clinical trial product is used.
Eye surgery within 12 weeks immediately prior to enrolment for this trial.
Previous corneal refractive surgery.
Known allergy or intolerance to ingredients in any of the diagnostic products used during the clinical trial.
Currently enrolled in another clinical trial.
Participation in a clinical trial within the previous 2 weeks for dispensing studies and 48 hours between in-house studies.
Pregnancy: Formal testing of pregnancy is not required. A participant’s verbal report is sufficient.
The Investigator may, at his / her discretion, exclude anyone who they believe may not be able to fulfil the clinical trial requirements or it is believed to be in the participant’s best interests.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Random sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/07/2012
Actual
27/07/2012
Date of last participant enrolment
Anticipated
Actual
23/04/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285543 0
Charities/Societies/Foundations
Name [1] 285543 0
Brien Holden Vision Institute
Country [1] 285543 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Brien Holden Vision Institute
Address
Level 5, Rupert Myers Building Gate 14, Barker
Street University of New South Wales, NSW
2052
Country
Australia
Secondary sponsor category [1] 284382 0
None
Name [1] 284382 0
Address [1] 284382 0
Country [1] 284382 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287563 0
Bellberry Limited
Ethics committee address [1] 287563 0
Ethics committee country [1] 287563 0
Australia
Date submitted for ethics approval [1] 287563 0
02/07/2012
Approval date [1] 287563 0
24/07/2012
Ethics approval number [1] 287563 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34380 0
Mr Daniel Tilia
Address 34380 0
Level 5, North Wing, RMB, Gate 14, Barker Street, The University of New South Wales SYDNEY NSW 2052
Country 34380 0
Australia
Phone 34380 0
+61293857516
Fax 34380 0
Email 34380 0
d.tilia@brienholdenvision.org
Contact person for public queries
Name 17627 0
Daniel Tilia
Address 17627 0
Level 5, North Wing, RMB, Gate 14, Barker Street,
The University of New South Wales
SYDNEY NSW 2052
Country 17627 0
Australia
Phone 17627 0
+61293857516
Fax 17627 0
Email 17627 0
d.tilia@brienholdenvision.org
Contact person for scientific queries
Name 8555 0
Daniel Tilia
Address 8555 0
Level 5, North Wing, RMB, Gate 14, Barker Street,
The University of New South Wales
SYDNEY NSW 2052
Country 8555 0
Australia
Phone 8555 0
+61293857516
Fax 8555 0
Email 8555 0
d.tilia@brienholdenvision.org

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
No additional documents have been identified.