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NCT Number: NCT02417116

Tear Osmolarity Clinical Utility in Dry Eye Disease

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.

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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Robert Frith Opticians, Shaftesbury, Dorest, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tear supplement

Other

Application as required to improve comfort

Other names: Hypermellose 0.3% eye drop

Tear supplement 2

Other

Application as required to improve comfort

Other names: Hylo-Forte 0.2% Sodium Hyaluronate eye drop

Omega 3 nutrition supplement

Dietary Supplement

Taken each day

Other names: Scope Ophthalmics Omega Eye

Eye bag

Device

Applied following microwave heating to closed eyelids for 5 minutes each day

Other names: TranquilEyes Moist Heat Lid

Saline

Other

Application as required to improve comfort

Other names: Minim sodium chloride 0.9% unpreserved

Primary outcomes

  1. Osmolarity change

    Time frame: 3 months

    Salt balance in tears measured with the Tearlab

Secondary outcomes

  1. Tear break-up time change

    Time frame: 3 months

    Tear stability following a blink

  2. 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. Meibomian gland change

    Time frame: 3 months

    Grading of meibomian glands using Oxford scale

  4. Tear Meniscus Height

    Time frame: 3 months

    Height of tear meniscus along the lower lid margin observed through a slit-lamp microscope

  5. SPEED Questionnaire change

    Time frame: 3 months

    Dry eye symptomology questionnaire

Sponsors and collaborators

Lead sponsor

Aston University

Other

Collaborators

  • TearLab Corporation

Registry information

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Apr 15, 2015
Registry last updated
Jan 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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