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Tear Osmolarity Clinical Utility in Dry Eye Disease

NCT02417116 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2019-01-10

No results posted yet for this study

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.

Conditions

  • Dry Eye

Interventions

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

Sponsors & Collaborators

  • TearLab Corporation

    collaborator INDUSTRY

  • Aston University

    lead OTHER

Principal Investigators

  • James Wolffsohn, BSc MBA PhD · Aston University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2019-01-31
Completion
2019-01-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02417116 on ClinicalTrials.gov