NCT02417116

Tear Osmolarity Clinical Utility in Dry Eye Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Aston University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dry Eye

Interventions

Type	Name	Description
OTHER	Tear supplement	Application as required to improve comfort
OTHER	Tear supplement 2	Application as required to improve comfort
DIETARY_SUPPLEMENT	Omega 3 nutrition supplement	Taken each day
DEVICE	Eye bag	Applied following microwave heating to closed eyelids for 5 minutes each day
OTHER	Saline	Application as required to improve comfort

Timeline

• Start date: 2015-06-01
• Primary completion: 2019-01-01
• Completion: 2019-01-01
• First posted: 2015-04-15
• Last updated: 2019-01-10

Locations

6 sites across 1 country: United Kingdom