Clinical trial NCT02417116: Tear Osmolarity Clinical Utility in Dry Eye Disease
Official title: Tear Osmolarity Clinical Utility in Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Lead sponsor: Aston University
Sponsor class: OTHER
Collaborators: name: TearLab Corporation
First posted: 2015-04-15
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Osmolarity change
timeFrame: 3 months
Secondary outcomes:
measure: Tear break-up time change
timeFrame: 3 months
measure: Corneal staining change
timeFrame: 3 months
measure: Meibomian gland change
timeFrame: 3 months
measure: Tear Meniscus Height
timeFrame: 3 months
measure: SPEED Questionnaire change
timeFrame: 3 months
Other outcomes:
Locations:
city: Shaftesbury
country: United Kingdom
facility: Robert Frith Opticians
state: Dorest
city: Blandford Forum
country: United Kingdom
facility: Robert Frith Opticians
state: Dorset
city: Gillingham
country: United Kingdom
facility: Robert Frith Opticians
state: Dorset
city: Twickenham
country: United Kingdom
facility: Robert Frith Opticians
state: Middlesex
city: Ayr
country: United Kingdom
facility: Black & Lizars Optometrists
city: Glasgow
country: United Kingdom
facility: Black & Lizars Optometrists
Study officials:
affiliation: Aston University
name: James Wolffsohn, BSc MBA PhD
role: PRINCIPAL_INVESTIGATOR
References: