Tear Osmolarity Clinical Utility in Dry Eye Disease

January 9, 2019 updated by: Aston University

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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Ayr, United Kingdom, KA7 1UL
        • Black & Lizars Optometrists
      • Glasgow, United Kingdom, G46 6JB
        • Black & Lizars Optometrists
    • Dorest
      • Shaftesbury, Dorest, United Kingdom, SP7 8AR
        • Robert Frith Opticians
    • Dorset
      • Blandford Forum, Dorset, United Kingdom, DT11 8AR
        • Robert Frith Opticians
      • Gillingham, Dorset, United Kingdom, SP8 4AA
        • Robert Frith Opticians
    • Middlesex
      • Twickenham, Middlesex, United Kingdom, TW1 4BW
        • Robert Frith Opticians

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
Minims Saline (Preservative Free) lubricant eye drops - daily for 90 days
Other: Saline
Application as required to improve comfort
Other Names:
  • Minim sodium chloride 0.9% unpreserved
Active Comparator: Hypromellose - standard treatment
Tear Supplement: Hypromellose 0.3% eye drops - daily for 90 days
Other: Tear supplement
Application as required to improve comfort
Other Names:
  • Hypermellose 0.3% eye drop
Active Comparator: Combination treatment
Tear Supplement 2: Hylo-Forte 0.2% Sodium Hyaluronate eye drops, Omega 3 nutrition supplement: Omega-3 tablets, Eye bag: TranquilEyes Moist Heat Lid Compresses - Daily for 90 days;
Other: Tear supplement 2
Application as required to improve comfort
Other Names:
  • Hylo-Forte 0.2% Sodium Hyaluronate eye drop
Dietary supplement: Omega 3 nutrition supplement
Taken each day
Other Names:
  • Scope Ophthalmics Omega Eye
Device: Eye bag
Applied following microwave heating to closed eyelids for 5 minutes each day
Other Names:
  • TranquilEyes Moist Heat Lid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Osmolarity change
Time Frame: 3 months
Salt balance in tears measured with the Tearlab
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tear break-up time change
Time Frame: 3 months
Tear stability following a blink
3 months
Corneal staining change
Time Frame: 3 months
Fluorescein dye applied to the ocular surface and observed with blue light and a yellow filter to observe staining fluorescence
3 months
Meibomian gland change
Time Frame: 3 months
Grading of meibomian glands using Oxford scale
3 months
Tear Meniscus Height
Time Frame: 3 months
Height of tear meniscus along the lower lid margin observed through a slit-lamp microscope
3 months
SPEED Questionnaire change
Time Frame: 3 months
Dry eye symptomology questionnaire
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aston University

Collaborators

TearLab Corporation

Investigators

  • Principal Investigator: James Wolffsohn, BSc MBA PhD, Aston University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2015

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

April 10, 2015

First Submitted That Met QC Criteria

April 10, 2015

First Posted (Estimate)

April 15, 2015

Study Record Updates

Last Update Posted (Actual)

January 10, 2019

Last Update Submitted That Met QC Criteria

January 9, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TP00128

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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