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.

Study Overview

• Status: Completed
• Conditions: Dry Eye
• Intervention / Treatment: Other: Saline; Other: Tear supplement; Other: Tear supplement 2; Dietary supplement: Omega 3 nutrition supplement; Device: Eye bag

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

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

Eligibility Criteria

• Ages Eligible for Study: 14 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

How is the study designed?

Design Details

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

Number of Arms

3

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	Salt balance in tears measured with the Tearlab	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tear break-up time change	Tear stability following a blink	3 months
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
Meibomian gland change	Grading of meibomian glands using Oxford scale	3 months
Tear Meniscus Height	Height of tear meniscus along the lower lid margin observed through a slit-lamp microscope	3 months
SPEED Questionnaire change	Dry eye symptomology questionnaire	3 months

Collaborators and Investigators

• Sponsor: Aston University
• Collaborators: TearLab Corporation
• Investigators: Principal Investigator: James Wolffsohn, BSc MBA PhD, Aston University

Study record dates

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: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Pharmaceutical Solutions; Viscosupplements; Ophthalmic Solutions; Hyaluronic Acid
• Other Study ID Numbers: TP00128