The Value of Tear Osmolarity as a Metric in Evaluating the Response to Dry Eye Therapy in the Clinic and in Clinical Trials – Accepted Manuscript
In this issue, Amparo and colleagues purport that tear osmolarity has little utility in assessing therapeutic changes in dry eye patients. We will explain how this faulty conclusion is a direct result of an uncontrolled, biased trial design, and that a well known phenomenon, “mean regression2”, predetermined the outcome, leading the authors to draw conclusions based entirely on statistical artifact. The study raises broader issues as to how physicians should diagnose, treat and monitor complex disorders where signs show different degrees of sensitivity and specificity, as this has relevance to a number of ophthalmic disorders including dry eye disease (DED).