Dry Eye
Conditions
Brief summary
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
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.
Interventions
OTHERTear supplement
Application as required to improve comfort
OTHERTear supplement 2
Application as required to improve comfort
DIETARY_SUPPLEMENTOmega 3 nutrition supplement
Taken each day
DEVICEEye bag
Applied following microwave heating to closed eyelids for 5 minutes each day
OTHERSaline
Application as required to improve comfort
Sponsors
TearLab Corporation
Aston University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Osmolarity change | 3 months | Salt balance in tears measured with the Tearlab |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Meibomian gland change | 3 months | Grading of meibomian glands using Oxford scale |
| Tear break-up time change | 3 months | Tear stability following a blink |
| Corneal staining change | 3 months | Fluorescein dye applied to the ocular surface and observed with blue light and a yellow filter to observe staining fluorescence |
| Tear Meniscus Height | 3 months | Height of tear meniscus along the lower lid margin observed through a slit-lamp microscope |
| SPEED Questionnaire change | 3 months | Dry eye symptomology questionnaire |
Countries
United Kingdom
Outcome results
None listed