RecruitingACTRN12625000028404

Evaluation of a new biomarker for tear film health

Evaluation of a new biomarker for tear film health in individuals with tear dysfunction

Sponsor

The University of Melbourne

Enrollment

60 participants

Start Date

Mar 7, 2025

Study Type

Interventional

Conditions

Aqueous-deficient dry eye Meibomian gland dysfunction

Summary

As the most common indication for seeking medical eye care in developed countries, tear dysfunction is a major public health issue. The most common form of tear dysfunction is dry eye disease. At present, major barriers to optimal dry eye medical care are difficulties in reliably diagnosing and assessing the severity of the condition. There is therefore a need for new, rapid, cost-effective methods for detecting and staging dry eye, and tear dysfunction more generally, in clinical practice. This study seeks to evaluate a new method for analysing tear health, based upon quantifying biophysical attributes related to tear viscoelasticity, using a novel acoustically-driven microfluidic extensional rheometry platform. This study seeks to assess the therapeutic responsivity of the new method by examining correlations between the changes to dry eye clinical signs and ADMiER-derived tear rheology attributes, in response to established interventions for dry eye. We hypothesise that the viscoelastic properties of the tears will correlate to changes in the clinical signs and symptoms of dry eye disease.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Dry eye disease is one of the most common eye conditions in developed countries, affecting quality of life and causing discomfort, blurred vision, and a constant feeling that something is in the eye. Despite how common it is, dry eye can be difficult to diagnose accurately, and existing tests don't always tell clinicians exactly how severe the condition is or how well a patient is responding to treatment. This study is evaluating a new method for measuring the health of the tear film — the thin layer of fluid that protects and lubricates the eye. The technique, called acoustically driven microfluidic extensional rheometry, assesses the viscoelastic properties of tears (essentially, how the tears behave as a fluid) to provide a more objective and sensitive measure of tear health. The study will compare this new measurement against standard dry eye clinical tests and track changes in response to established dry eye treatments. You may be eligible if you are aged 18 or older, have symptoms of dry eye disease, and have been using a stable eye drop regimen for at least 30 days. Specific clinical eye test results are needed to qualify for each study subgroup. People who have had recent eye surgery, are pregnant or breastfeeding, use contact lenses, or have had certain laser or other dry eye treatments in the past 90 days would not be eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Intervention 1: Prednisolone Sodium Phosphate 0.5% 5mg/mL eye drops minims (Bausch & Lomb Australia Pty Ltd) Mode: topical ocular. Dose: one drop, both eyes, four times daily, self-administered by t

Intervention 1: Prednisolone Sodium Phosphate 0.5% 5mg/mL eye drops minims (Bausch & Lomb Australia Pty Ltd) Mode: topical ocular. Dose: one drop, both eyes, four times daily, self-administered by the participant. Duration: 14 days, ± 2 days. Treatment adherence will be monitored by the use of an at-home treatment tracking diary. Intervention 2: LipiFlow Thermal Pulsation (Johnson & Johnson Pty Ltd) Single dose of standard in-office standard therapy of 12 minutes duration, both eyes simultaneously. Administered by the study optometrist at day 14 ± 2 only to participants who do not show a clinical improvement in signs of dry eye ("treatment non-responders") after 14 days of treatment with Prednisolone Sodium Phosphate 0.5% 5mg/mL or placebo (saline (sodium chloride) 0.9%). Acoustically-driven microfluidic extensional rheometry: The novel extensional rheometry platform is a laboratory-based platform that can be used to analyse the rheological (stretching) properties of a tear sample. Tear samples collected from study participants are analysed on the platform at all study visits for all participants. The tear rheological analysis generated by the platform is a primary outcome of this study. Eligible participants will be assessed at baseline to be classified as being in one of two subgroups (aqueous-deficient dry eye or meibomian gland dysfunction) for the purposes of endpoint analysis and treatment response. All study procedures and interventions will be the same for participants in both subgroups. "Treatment responders" will exit the study after Day 14. "Treatment non-responders" will receive LipiFlow Thermal Pulsation at Day 14, as described above, and be re-assessed for treatment response at Day 42. Treatment ‘responders’ in the aqueous-deficient dry eye subgroup will be defined as individuals who show greater than or equal to 3 units improvement (NEI scale) in overall corneal fluorescein staining in the study eye. Treatment ‘responders’ in the meibomian gland dysfunction subgroup will be defined as those with an absolute MGYLS score of greater than or equal to 5 or a MGS of greater than or equal to 15 in the study eye.

Locations(1)

VIC, Australia

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ACTRN12625000028404