Abstract
Purpose :
Dry eye is generally classified as evaporative (EDE) or aqueous-deficient (non-EDE) dry eye. Clinical criteria to differentiate these two groups have been developed as a means to better assign appropriate therapies. This study applied these criteria to the dry eye populations enrolled in two randomized clinical trials, to explore the overall clinical differences between EDE and non-EDE patients, as well as their response to 3 months of treatment with an artificial tear containing two lubricant polymers.
Methods :
Data from 327 patients were included in this study. EDE was defined as tear break-up time (TBUT) of ≤ 7 secs, Schirmer test with anesthesia of ≥ 10 mm / 5 min, some observed ocular surface staining , and Ocular Surface Disease Index (OSDI) score of > 12. All other patients were classified as non-EDE. Baseline and change from baseline following 90 days of treatment with a carboxymethylcellulose/hyaluronic acid dual polymer artificial tear (OPTIVE Fusion, Allergan plc) were compared between EDE and non-EDE groups for OSDI, TBUT, corneal, conjunctival, and total staining, and symptoms by Visual Analog Scales (VAS).
Results :
28.4% (93/327) of the patient pool met the EDE criteria. At baseline, EDE and non-EDE patients had similar levels of OSDI, VAS symptoms, and TBUT, whereas, corneal and conjunctival staining trended to lower values in the EDE population. Following 3 months’ treatment, all signs and symptoms improved in both groups. There were trends towards greater improvements in Dryness, Grittiness/Foreign body sensation, and Burning/Stinging in the EDE group compared with the non-EDE group, and greater improvements in corneal and conjunctival staining in the non-EDE group.
Conclusions :
In this retrospective analysis of clinical trial data from a heterogeneous population of dry eye patients, less than a third of patients were classified as EDE. The non-EDE patients included both aqueous-deficient and patients with mixed etiology. Both EDE and non-EDE groups showed improvement in signs and symptoms of dry eye disease as a result of treatment, with some differences between the 2 groups. This analysis suggests that many evaporative dry eye patients also have a component of aqueous deficiency; however regardless of classification, both groups of patients showed improvement following dual-polymer artificial tear treatment.
This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.