Tear Osmolarity Clinical Utility in Dry Eye Disease

Study Overview
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Brief Summary
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Millions of people suffer from dry eye disease, causing symptoms such as redness, burning, feeling of sand or grit in the eye and light sensitivity. Dry eye disease occurs when your eyes do not produce enough tears or produce poor quality tears. This can happen for a number of reasons, including aging, hormonal changes in women and side effects of diseases or medications. It is now possible to objectively measure the degree of dry eye disease by collecting a tiny sample of tears from the corner of the eye and then measuring the amount of salt in the tears (termed osmolarity). We aim to establish the overall levels of raised and normal tear osmolarity in people presenting to the eye clinic with complaints of dry eye, and relate this to other factors such as symptoms, topical and nutritional medication and dry eye treatment.

Detailed Description
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This study will investigate the efficacy of two treatment non-pharmaceutical therapies (tear drop alone, tear drop combined with omega 3 nutritional supplement and warm compresses) for dry eye reporting patients against a control (saline) over a 3 month period. A relatively new clinical measure (osmolarity) will be performed alongside traditional tear film volume, tear film stability, gland integrity and ocular surface damage measures to determine how this influences symptomatic complaints.

Official Title
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Tear Osmolarity Clinical Utility in Dry Eye Disease

Conditions
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Dry Eye

Intervention / Treatment
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* Other: Tear supplement
* Other: Tear supplement 2
* Dietary Supplement: Omega 3 nutrition supplement
* Device: Eye bag
* Other: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Dry Eye Symptoms SPEED >8 Exclusion Criteria: Unable to participate in 90 days therapy Allergic to therapy On medication known to affect ocular surface / tear film Had ocular trauma, infection or surgery Diagnosed with a medical condition known to affect ocular surface / tear film

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Minims Saline (Preservative Free) lubricant eye drops - daily for 90 days | Other: Saline<br>* Application as required to improve comfort<br>* Other names: Minim sodium chloride 0.9% unpreserved;|
| Active Comparator: Hypromellose - standard treatment<br>Tear Supplement: Hypromellose 0.3% eye drops - daily for 90 days | Other: Tear supplement<br>* Application as required to improve comfort<br>* Other names: Hypermellose 0.3% eye drop;|
| Active Comparator: Combination treatment<br>Tear Supplement 2: Hylo-Forte 0.2% Sodium Hyaluronate eye drops, Omega 3 nutrition supplement: Omega-3 tablets, Eye bag: TranquilEyes Moist Heat Lid Compresses - Daily for 90 days; | Other: Tear supplement 2<br>* Application as required to improve comfort<br>* Other names: Hylo-Forte 0.2% Sodium Hyaluronate eye drop;Dietary Supplement: Omega 3 nutrition supplement<br>* Taken each day<br>* Other names: Scope Ophthalmics Omega Eye;Device: Eye bag<br>* Applied following microwave heating to closed eyelids for 5 minutes each day<br>* Other names: TranquilEyes Moist Heat Lid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Osmolarity change | Salt balance in tears measured with the Tearlab | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear break-up time change | Tear stability following a blink | 3 months | 
| Corneal staining change | Fluorescein dye applied to the ocular surface and observed with blue light and a yellow filter to observe staining fluorescence | 3 months | 
| Meibomian gland change | Grading of meibomian glands using Oxford scale | 3 months | 
| Tear Meniscus Height | Height of tear meniscus along the lower lid margin observed through a slit-lamp microscope | 3 months | 
| SPEED Questionnaire change | Dry eye symptomology questionnaire | 3 months |