The Schirmer test has been the gold standard for dry-eye testing for about a century. It consists of inserting strips of paper inside the patient’s bottom eyelids. In addition to many people finding this test unpleasant, false negatives and positives can be facilitated by the application of topical anesthetics or patient reaction to the test.
TearLab saw an opportunity to improve upon this test in ways that benefitted the patient as well as the physician. They developed an innovative method for measuring tear osmolarity which has been shown to be a more effective diagnostic method for dry eye syndrome than traditional techniques (with a PPV of 87 percent versus 25 to 31 percent). The test also takes a fraction of the time of the Schirmer test.
They approached us to design both a product solution that leveraged their intellectual property, and enabled a business solution that would reach the market quickly, respect their budget and meet their profit goals. The resulting osmolarity reader offers improved diagnostic performance as well as a more comfortable experience for the patient. It requires only 50 nL of fluid to take a measurement, reducing the time to administer the test from five minutes to just a few seconds.
The TearLab™ Osmolarity System is also the first CLIA-waived Point of Care (POC) eye care device to make it to market.