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Tear Osmolarity Clinical Utility in Dry Eye Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02417116
Recruitment Status : Completed
First Posted : April 15, 2015
Last Update Posted : January 10, 2019
TearLab Corporation
Information provided by (Responsible Party):
Aston University

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.

Condition or disease Intervention/treatment Phase
Dry Eye Other: Tear supplement Other: Tear supplement 2 Dietary Supplement: Omega 3 nutrition supplement Device: Eye bag Other: Saline Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tear Osmolarity Clinical Utility in Dry Eye Disease
Actual Study Start Date : June 2015
Actual Primary Completion Date : January 2019
Actual Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases Tears

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 Name: 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 Name: 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 Name: Hylo-Forte 0.2% Sodium Hyaluronate eye drop

Dietary Supplement: Omega 3 nutrition supplement
Taken each day
Other Name: Scope Ophthalmics Omega Eye

Device: Eye bag
Applied following microwave heating to closed eyelids for 5 minutes each day
Other Name: TranquilEyes Moist Heat Lid

Primary Outcome Measures :
  1. Osmolarity change [ Time Frame: 3 months ]
    Salt balance in tears measured with the Tearlab

Secondary Outcome Measures :
  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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02417116

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United Kingdom
Robert Frith Opticians
Shaftesbury, Dorest, United Kingdom, SP7 8AR
Robert Frith Opticians
Blandford Forum, Dorset, United Kingdom, DT11 8AR
Robert Frith Opticians
Gillingham, Dorset, United Kingdom, SP8 4AA
Robert Frith Opticians
Twickenham, Middlesex, United Kingdom, TW1 4BW
Black & Lizars Optometrists
Ayr, United Kingdom, KA7 1UL
Black & Lizars Optometrists
Glasgow, United Kingdom, G46 6JB
Sponsors and Collaborators
Aston University
TearLab Corporation
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Principal Investigator: James Wolffsohn, BSc MBA PhD Aston University

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Responsible Party: Aston University Identifier: NCT02417116     History of Changes
Other Study ID Numbers: TP00128
First Posted: April 15, 2015    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019

Additional relevant MeSH terms:
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Dry Eye Syndromes
Eye Diseases
Conjunctival Diseases
Corneal Diseases
Lacrimal Apparatus Diseases
Ophthalmic Solutions
Keratoconjunctivitis Sicca
Hyaluronic Acid
Pharmaceutical Solutions
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Protective Agents