None listed
Conditions
Brief summary
The purpose of this project is to evaluate the movement of immune cells that occur naturally in the clear window at the front of the eye (the cornea). This movement will be evaluated before and after the application of commercially available eye drops used to treat sign and symptoms of mild to severe dry eye. Immune cells with and without dendrites give the immune system the ability to sequester, tightly regulate, and increase the efficiency of defense against internal and external pathogens. Understanding the cell dynamics in healthy individuals will contribute to normative data to future studies on ocular and systemic diseases. In addition to assessing the corneal nerves, corneal confocal microscopy is also capable of detecting dendritic cells. These cells have a distinctive hyper-reflective shape and are located at the same depth of the corneal nerves, at approximately a 50 µm depth from corneal epithelium. Hence, the assessment of these two important ocular structures in a single image offers useful insight into the association and interaction between both; the nervous and immune systems of the ocular surface. The ability to observe and quantify migration rates of dendritic cells in vivo is likely to reveal previously unknown insights into corneal and general pathophysiology and may serve as an effective biomarker to intervention therapies. The dynamics of corneal resident dendritic cells located at the corneal sub-basal nerve plexus may provide a powerful approach to understanding the spectrum of immune and neurological diseases with applications in observational and analytic epidemiology, randomised clinical trials, screening and diagnosis and prognosis. DC dynamics have the potential to also reflect the entire spectrum of autoimmune diseases from the earliest manifestations to the terminal stages. The behaviour of these cells could potentially offer the means for homogeneous classification of autoimmune and systemic disease and risk factors, and also extend our base information about the underlying pathogenesis of immune diseases.
Interventions
The primary objective of the study is to determine immune cell dynamics before and after the use of topical anti-inflammatory and immunosuppressive eyedrops. This intervention will determine if presumed immune cells with morphological characteristics of resident corneal dendritic cells, as observed in a time-lapsed manner using In vivo confocal microscopy are indeed immune cells of the cornea.
All ocular topical medication chosen in the study is carefully selected from eye care professionals
The primary objective of the study is to determine immune cell dynamics before and after the use of topical anti-inflammatory and immunosuppressive eyedrops. This intervention will determine if presumed immune cells with morphological characteristics of resident corneal dendritic cells, as observed in a time-lapsed manner using In vivo confocal microscopy are indeed immune cells of the cornea. All ocular topical medication chosen in the study is carefully selected from eye care professionals considering less participant risk and better safety profiles for each drug category. A total of 90 healthy individuals will be randomly assigned to one of the three groups of approximately 30 each. The participant will be masked to group assignment. The clinician that will be administering the treatment cannot be masked due to differences in the drug packaging. All other study personnel that will be assessing the outcomes and analysing the results/data will be masked. Group one will act as the control group. Group two will receive a single drop of ocular anti-inflammatory eye drops: FLUCON® Eye Drops 0.1% (fluorometholone— Flucon®, Alcon Laboratories Pty. Ltd., Fort Worth, TX, USA) Flucon eye drops are used to treat the redness, swelling, and other symptoms of eye inflammation. Flucon eye drops contain the active ingredient fluorometholone acetate. Fluorometholone belongs to a class of medicines known as "steroids" or "corticosteroids" which reduce inflammation. The active drug is fluorometholone (1 mg/mL). A qualified optometrist will be applying the drops to the right eye of eligible participants after ocular evaluation using confocal microscopy. Group three will receive a single drop of immunosuppressive eye drop: XIIDRA® Lifitegrast 50 mg/mL eye drops, single-dose containers solution (NOVARTIS Pharmaceuticals Australia Pty Limited) XIIDRA is an eye drop containing the medicine lifitegrast. Lifitegrast is a type of medicine called an 'LFA-1 antagonist' (LFA-1 stands for 'lymphocyte function-associated antigen-1'). It is used to treat moderate to severe dry eye disease in adults for whom prior use of artificial tears has not been sufficient. It works by decreasing inflammation in dry eye disease. A qualified optometrist will be applying the drops to the right eye of eligible participants after ocular evaluation using confocal microscopy. Note that most side effects of the topical eye drops used in the study are likely reported only in prolonged drug exposure. Only a single eyedrop will be applied during the one visit of the study. Ocular surface absorption is less than 10% of the dose. Systemic side effects of medication are minimal due to mechanisms of ocular drug absorption (absorption occurs directly into the eye before reaching the systemic circulation).
Sponsors
Queensland University of Technology
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Participants must satisfy the following conditions prior to inclusion in the study: A) Aged at least 18 years B) Good ocular health C) Willing and able to comply with protocol (e.g. attend study visit) D) Existing wearers should discontinue lens wear for at least 24 hours prior to examination. E) Participants without dry eye will be included. F) Former contact lens wearers will be included
Exclusion criteria
Any of the following will render a participant ineligible for inclusion: A) Current pregnancy, breastfeeding or traying to become pregnant B) History of ocular trauma or surgery such as LASIK or PRK C) Current or long-term use of topical ocular medication D) Ocular disease or systemic disease that may affect the cornea or conjunctiva (epithelial defects, ulcers and corneal epithelial or basement membrane dystrophies). E) Use of orthokeratology contact lenses within the past 3 months G) Use of soft contact lenses in either eye within 1 month of the study or rigid gas permeable contact lenses within 3 months of the study H) Dry eye disease (defined as defined as a 5-Item dry eye questionnaire (DEQ-5) score equal to 7. AND failing at least one of the objective dry eye tests Non-Invasive Break-Up Time with less than or equal to 10s, or Corneal Fluorescein Staining with greater than or equal to 5 corneal spots. (Note: both eyes will be assessed, and the worst eye will contribute toward the dry eye diagnosis) H) Allergy to fluorometholone, lifitegrast or any of the excipients of the study drugs
Outcome results
None listed