TEAR News Groundbreaking Osmolarity Prevalence Study Presented at ASCRS 2012
2012-04-23 11:15 ET - News Release
SAN DIEGO, April 23, 2012 (GLOBE NEWSWIRE) -- TearLab Corporation (Nasdaq:TEAR) (TSX:TLB) ("TearLab" or the "Company") announced that, today at the American Society of Cataract and Refractive Surgery 2012 Annual Meeting in Chicago, IL, prominent LASIK surgeon, Dr. Eric Donnenfeld, presented an interim analysis from a multicenter study designed to determine the overall prevalence of normal and abnormal tear fluid osmolarity in the patient population of clinicians who use the TearLab® Osmolarity System.
Normal tear film is in homeostasis with blood osmolarity at a reference value of 290 mOsm/L, with a normal "homeostatic range" for tear osmolarity defined as 275 - 307 mOsm/L. Hyperosmolarity is defined as a tear fluid osmolarity value in excess of the homeostatic range (greater or equal to 308 mOsm/L) in one or both eyes, and is used as a benchmark of dry eye disease ("DED").
The study involved 1,019 adult subjects (647 female, 372 male) from 16 sites across the United States and Europe. All patients in the study demonstrated at least three of the following nine binary symptoms: fluctuating vision, contact lens discomfort, light sensitivity, watery eyes, tired eyes, redness, burning, itching and sand or grit.
The overall incidence of hyperosmolarity amongst the study population was 43.4%. Importantly, of the 42.4% of subjects who reported symptoms of DED, just 47.7% actually had the disease while 52.3% had some other form of ocular irritation. Conversely, of the 57.6% of study subjects that were asymptomatic, 40.2% actually had mild-to-moderate DED while 59.8% were within the normal homeostatic range.
Dr. Donnenfeld commented, "It has long been recognized that patient symptoms do not correlate with DED or disease severity. These findings confirm that. Patients may be asymptomatic for DED, but still present with hyperosmolarity. The good news is that eye doctors now have an objective tool to assess tear film health. Identification of asymptomatic DED by performing TearLab Osmolarity testing is particularly important prior to contact lens wear and before LASIK or cataract surgery as a dysfunctional tear film may pose a health risk and/or negatively impact surgical outcomes."
