Tear Osmolarity Clinical Utility in Dry Eye Disease

Dry Eye Clinical Trial

Official title:

Tear Osmolarity Clinical Utility in Dry Eye Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02417116
• Other study ID #: TP00128
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: January 2019

Study information

• Verified date: January 2019
• Source: Aston University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Other:
• Tear supplement
Application as required to improve comfort
• 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

Locations

Country	Name	City	State
United Kingdom	Black & Lizars Optometrists	Ayr
United Kingdom	Robert Frith Opticians	Blandford Forum	Dorset
United Kingdom	Robert Frith Opticians	Gillingham	Dorset
United Kingdom	Black & Lizars Optometrists	Glasgow
United Kingdom	Robert Frith Opticians	Shaftesbury	Dorest
United Kingdom	Robert Frith Opticians	Twickenham	Middlesex

Sponsors (2)

Lead Sponsor	Collaborator
Aston University	TearLab Corporation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Osmolarity change	Salt balance in tears measured with the Tearlab	3 months
Secondary	Tear break-up time change	Tear stability following a blink	3 months
Secondary	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
Secondary	Meibomian gland change	Grading of meibomian glands using Oxford scale	3 months
Secondary	Tear Meniscus Height	Height of tear meniscus along the lower lid margin observed through a slit-lamp microscope	3 months
Secondary	SPEED Questionnaire change	Dry eye symptomology questionnaire	3 months