Tear Osmolarity Clinical Utility in Dry Eye Disease

Aston University

Status: Completed

Conditions: Dry Eye

Treatments: Other: Tear supplement 2; Dietary Supplement: Omega 3 nutrition supplement; Device: Eye bag; Other: Tear supplement; Other: Saline

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02417116

TP00128

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

Minims Saline (Preservative Free) lubricant eye drops - daily for 90 days

Treatment:

Other: Saline

Hypromellose - standard treatment

Active Comparator group

Description:

Tear Supplement: Hypromellose 0.3% eye drops - daily for 90 days

Treatment:

Other: Tear supplement

Combination treatment

Active Comparator group

Description:

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;

Treatment:

Device: Eye bag

Dietary Supplement: Omega 3 nutrition supplement

Other: Tear supplement 2