Tear Osmolarity Clinical Utility in Dry Eye Disease

Not Applicable

Completed

• Conditions: Dry Eye
• Interventions: Other: Saline; Other: Tear supplement; Other: Tear supplement 2; Dietary Supplement: Omega 3 nutrition supplement; Device: Eye bag

• Registration Number: NCT02417116
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2015-04-10
• Study First Submitted QC: 2015-04-10
• Study First Posted: 2015-04-15
• Study Start: 2015-06
• Status Verified: 2019-01
• Primary Completion: 2019-01
• Study Completion: 2019-01
• Last Update Submitted: 2019-01-09
• Last Update Posted: 2019-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Dry Eye Symptoms SPEED >8

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Saline	Minims Saline (Preservative Free) lubricant eye drops - daily for 90 days
Hypromellose - standard treatment	Tear supplement	Tear Supplement: Hypromellose 0.3% eye drops - daily for 90 days
Combination treatment	Eye bag	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;
Combination treatment	Omega 3 nutrition supplement	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;
Combination treatment	Tear supplement 2	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;

Primary Outcome Measures

Name	Time	Method
Osmolarity change	3 months	Salt balance in tears measured with the Tearlab

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Black & Lizars Optometrists; 🇬🇧 Glasgow, United Kingdom

Robert Frith Opticians; 🇬🇧 Twickenham, Middlesex, United Kingdom