The TearLab Osmolarity Core Validation Study, a multicentre international clinical study assessing the efficacy of the TearLab Osmolarity System for the diagnosis of dry eye disease, has been launched by the system's maker, OccuLogix Inc, and sponsored by Alcon.
The TearLab System measures the osmolarity of tears to quantify the severity of dry eye disease. The System requires less than 50 nL of tears and gives a result in 30 seconds. Each of the 500 subjects in the study (from Europe, Japan and the US), some of whom have a pre-existing diagnosis of dry eye, will have their tear osmolarity assessed once at a single visit, and the results will be compared with those obtained using traditional diagnostic tools.
OccuLogix anticipates that it will have completed patient enrollment by the end of the second quarter of 2009.