Trial | NCT02417116  Report issue

Official Title

Tear Osmolarity Clinical Utility in Dry Eye Disease

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    icosapent ethyl ...

  • Study Participants

    120
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.
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 Started
Jun 30
2015
Primary Completion
Jan 31
2019
Study Completion
Jan 31
2019
Last Update
Jan 10
2019

Other Tear supplement

Application as required to improve comfort

  • Other names: Hypermellose 0.3% eye drop

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

Other Saline

Application as required to improve comfort

  • Other names: Minim sodium chloride 0.9% unpreserved

Control Placebo Comparator

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

Hypromellose - standard treatment Active Comparator

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

Combination treatment Active Comparator

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;

Criteria 

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
No Results Posted