SAN DIEGO, March 11, 2009 (GLOBE NEWSWIRE) -- OccuLogix, Inc. dba TearLab Corporation (Nasdaq:TEAR) (TSX:TLB) today announced that it has initiated an international clinical study which is designed to demonstrate the efficacy of the TearLab(tm) Osmolarity System as a practical tool for the diagnosis and assessment of severity of Dry Eye Disease (DED) by measuring the osmolarity of tears. Osmolarity, simply stated, is a measure of the concentration of particles or solute per liter of solution.
DED, a disorder of the tear film caused by tear deficiency or excessive tear evaporation, currently affects 100 million people worldwide. If left untreated, DED is associated with pain, discomfort and may ultimately lead to future implications. "DED is highly treatable but difficult to diagnose quickly," said Gary Foulks, M.D., study investigator and professor of ophthalmology at the University of Louisville. "Untreated DED can be a cause of pain and frustration for patients and physicians. There is a great need for a screening tool that will provide immediate and accurate point of care diagnosis of this condition."
The TearLab(tm) Osmolarity System Core Validation Study is a 10-site clinical study that will enroll up to 500 subjects at sites in the United States, Europe and Japan. Inclusion criteria includes patients with or without a history of DED. Enrollment is expected to be completed by the end of the second quarter of 2009. Alcon, the world's leading eye care company, is a sponsor of the study.
By using osmolarity values derived from the TearLab(tm) Osmolarity System, clinical investigators will evaluate the validity of the system to diagnose DED and the severity of the disease. The TearLab(tm) Osmolarity System will be compared with current diagnostic tools clinicians use to establish DED. Subjects will be assessed at a single visit and the diagnosis will be based on positive responses using established objective and subjective criteria.
The TearLab(tm) Osmolarity System
The TearLab(tm) Osmolarity System uses a novel lab-on-a-chip approach that requires less than 50 nL (nanoliters) of tear fluid in order to measure tear osmolarity. By using such a small amount of tears, the TearLab(tm) Osmolarity System eliminates the challenges that previously prevented point-of-care osmolarity testing. The TearLab(tm) system can produce a sample-to-answer result in less than 30 seconds and is simple enough to be operated by a technician.
About OccuLogix, Inc. dba TearLab Corporation
OccuLogix dba TearLab Corporation (www.tearlab.com) is an in-vitro diagnostics company that develops and commercializes a proprietary tear testing platform, TearLab(tm), for use in the physician and clinical office. The Company employs lab-on-a-chip technologies (integrating one or several laboratory functions on a chip only millimeters in size) that enable healthcare practitioners to rapidly test for highly sensitive and specific biomarkers in tears at the point-of-care. Headquartered in San Diego, CA and with offices in Milton, Ontario and Alpharetta, GA, TearLab Corporation's common shares trade on the NASDAQ Global Market under the symbol 'TEAR' and on the Toronto Stock Exchange under the symbol 'TLB'. TearLab received the CE Mark for its TearLab(tm) Osmolarity System in 2008. The TearLab(tm) Osmolarity System is currently available in the U.S. for investigational use only.
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