A newly completed U.S. clinical study might pave the way for a new diagnostic test for dry eye syndrome.
Developed by DiagnosTear Ltd., TeaRx™ diagnostic tests are intended to provide a point-of-care multi-parameter test which is more evidence-based than the subjective evaluation that is the current norm. The trial, conducted by Ora, Inc. Andover, MA, compared these widely used benchmark tests for dry eye with its TeaRx™ diagnostic parameters that test components of tear film.
It was a prospective study consisting of approximately 200 subjects, widely-used benchmark tests for dry eye were compared with the TeaRx™ diagnostic parameters, including Schirmer’s test, TFBUT (Tear-Film Break-Up Time), staining of corneal and conjunctival epithelial cell damage and patient questionnaires. The study analysis was based on testing the sample extremes, quartiles 1 and 4, representing those enrolled subjects with largest differences for each metric.
Positive statistical correlations were identified between TeaRx™ diagnostic parameters and the currently used benchmark tests, leading BioLight Life Sciences Investments Ltd., of which DiagnosTear Ltd. is a subsidiary, to state that the results indicates a unique ability for improving the dry eye syndrome diagnosis by objective quantification of measures over subjective evaluation.
The company plans to initiate a second clinical trial in order to assess the effectiveness of the tests in tears of healthy subjects as well as patients with severe dry eye syndrome. Those trial results are expected in Q2 2015 and should enable the company to specifically define the combination of parameters to be part of a commercially available diagnostic kit and then initiate the regulatory processes for the kit. Assuming the completion of a successful development and regulatory process, BioLight expects to obtain regulatory approvals and launch the multi-parameter test kit in 2016.
George Ousler, Ora Inc. Vice President, Dry Eye said: “Dry eye is a complex, multifactorial disease, and currently available therapeutics are effective in treating only a small portion of the patient population. The variability that characterizes this disease complicates proper diagnosis and has hindered the development of reliable diagnostic tests. The TeaRx™ Diagnostic is a simple, robust test that identifies patients with one or more of the underlying causes of dry eye. The results of the study showed a high correlation between the test parameters and the signs and symptoms of dry eye – this represents a major advancement in the proper diagnosis of dry eye and provides physicians an efficient approach to selecting treatments for individual patients.”
BioLight’s CEO, Suzana Nahum-Zilberberg said: “Our TeaRx™ technology’s unique approach has the potential to solve the unmet needs for hundreds of millions of patients suffering from dry eye syndrome. The ability to diagnose this complex multi-faceted syndrome, using a , is a novel approach, which is aimed to improve the diagnosis and treatment of a large and growing patient population world-wide. In addition, this test has the potential to identify sub-groups of dry eye syndrome patients which could lead to the development of new therapies to treat the syndrome, as well as additional companion diagnostic tools.”
Source: BioLight Life Sciences Investments Ltd.