The age-related changes of the meibomian glands in healthy participants

Not Applicable

Completed

• Conditions: Meibomian gland dysfunction; Dry eye; Eye - Normal eye development and function

• Registration Number: ACTRN12612000703808
• Lead Sponsor: Brien Holden Vision Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-07-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

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”

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

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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[Baseline visit]

Secondary Outcome Measures

Name	Time	Method
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[Baseline visit];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[Baseline visit];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.[Baseline visit];Standardised questionnaire: The Victorian Cancer Council food frequency questionnaire will be used to determine whether diet influences meibomian gland dysfunction[Baseline visit]