None listed
Conditions
Brief summary
This trial will assess age-related changes to the meibomian gland in a population aged between 25 and less than 65 years of age
Interventions
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.
Sponsors
Eligibility
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.