SAN DIEGO, Sept. 4, 2014 (GLOBE NEWSWIRE) -- TearLab Corporation (Nasdaq:TEAR) (TSX:TLB) ("TearLab" or the "Company") today announced interim results of a multi-center dry eye disease ("DED") prevalence study being carried out in the United Kingdom at four National Health Service ("NHS") hospitals.
Interim results from 596 patients show that current DED tests do not correlate well with the presence of the disease and that almost half of all cases have conflicting diagnosis.
The study, conducted under the auspices of the UK's National Institute of Health Research, commenced in March and its interim phase was completed in June. It involved masking the TearLab® Osmolarity test results and comparing those with the results of other commonly used tests to evaluate DED.
These are:
- OSDI – (Ocular Surface Disease Index) Dry Eye Symptom questionnaire
- TBUT – Tear Break Up Time - defined as the interval between the last complete blink and the first appearance of a dry spot, or disruption in the tear film.
- Staining - Surface damage to the exposed eye, assessed by staining, is graded against standard charts.
- MGD - Meibomian gland dysfunction – the ophthalmologist applies pressure to the eyelids to check if they are expressing lipids necessary for ocular health.
- DEWS – a composite score based on the above tests, applying the conclusions of the International Dry Eye Workshop (DEWS) findings.
The interim clinical trial results show:
- Osmolarity had the highest agreement with the DEWS score.
- Ophthalmologists primarily rely upon TBUT and Staining for their diagnosis.
- Symptoms alone had higher agreement with DEWS score than the ophthalmologist's diagnosis.
- 20.1% of patients (120 individuals) had significant symptoms but no other sign of dry eye except for hyperosmolarity (336.8 mOsm/L). Without an osmolarity test, doctors were only able to diagnose 34 of these symptomatic patients (28.3%) with DED.
"The interim results of this study could have far reaching consequences for the evaluation, diagnosis and management of dry eye disease in the UK," said Lead Investigator, Consultant Ophthalmologist Francesca Harman, from Hillingdon Hospital. "Dry eye disease can compromise a patient's cornea and cause constant irritation and discomfort. We hope this large-scale prevalence study will improve correct diagnosis of DED."
Hospital eye care accounts for 8.6% of all outpatient activity in NHS England, second only to orthopedics and trauma, representing a major and ever-increasing cost burden. New diagnostic technology, such as tear osmolarity tests, to properly diagnose chronic eye diseases and improve the quality of new referrals from primary into secondary care may optimize patient flow through ophthalmology clinics and ease this cost burden.
Dr. Harman concluded, "The study also shows the need for objective testing to be introduced to the NHS."
About TearLab Corporation
TearLab Corporation (www.tearlab.com) develops and markets lab-on-a-chip technologies that enable eye care practitioners to improve standard of care by objectively and quantitatively testing for disease markers in tears at the point-of-care. The TearLab® Osmolarity Test, for diagnosing Dry Eye Disease, is the first assay developed for the award-winning TearLab Osmolarity System. Headquartered in San Diego, CA, TearLab Corporation's common shares trade on the NASDAQ Capital Market under the symbol 'TEAR' and on the Toronto Stock Exchange under the symbol 'TLB.'
Forward-Looking Statements
This press release may contain forward-looking statements. These statements relate to future events and are subject to risks, uncertainties and assumptions about TearLab. Examples of forward-looking statements in this press release include statements regarding the future potential of the TearLab Osmolarity System and the related impact on our sales. These statements are only predictions based on our current expectations and projections about future events. You should not place undue reliance on these statements. Actual events or results may differ materially. Many factors may cause our actual results to differ materially from any forward-looking statement, including the factors detailed in our filings with the Securities and Exchange Commission and Canadian securities regulatory authorities, including but not limited to our Annual Report on Form 10-K for the year ended December 31, 2013, filed with the SEC on March 17, 2014, and our Quarterly Report on Form 10-Q for the quarter ended June 30, 2014, filed with the SEC on August 8, 2014. We do not undertake to update any forward-looking statements.