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Response of evaporative dry eye patients to treatment with a dual-polymer artificial tear

Poster Details

First Author: O.Kadaifci TURKEY

Co Author(s):    P. Simmons   H. Liu   J. Vehige   D. Hollander     

Abstract Details

Purpose:

Dry eye disease is generally classified as either evaporative or aqueous-deficient. Artificial tears are used as either primary therapy or as concomitant therapy for patients at all levels of severity, regardless of etiology. This study examined clinical results from 2 randomized, controlled clinical trials to determine difference in baseline characteristics and treatment response between patients classified as either evaporative dry eye (EDE) or non-evaporative dry eye (non-EDE). In both trials, patients used a preserved or non-preserved artificial tear containing both carboxymethylcellulose (CMC) and hyaluronic acid (HA) polymers, in comparison with single-polymer tears.

Setting:

Retrospective analysis of data from 2 multi-center, randomized, controlled clinical trials, with clinical sites in Australia, Canada, France, Germany, Italy, Russia, Spain, and the United Kingdom.

Methods:

EDE was defined as tear break-up time (TBUT) of <= 7 secs, Schirmer test with anesthesia of >=10 mm / 5 min, ocular surface staining, and Ocular Surface Disease Index (OSDI) score of >12. Other patients were non-EDE. 100 subjects using OPTIVE Fusion multidose (OFM, Allergan) in Trial 1 and 227 patients using OPTIVE Fusion UD (OFU, Allergan) in Trial 2 were analyzed. Baseline and change from baseline through 90 days of treatment were compared between EDE and non-EDE groups for OSDI, TBUT, corneal, conjunctival, and total staining, and symptoms by Visual Analog Scales (VAS).

Results:

17 EDE and 83 non-EDE patients were identified in Trial 1 and 76 EDE and 151 non-EDE patients in Trial 2. At baseline, EDE and non-EDE patients had similar levels of severity in most study variables. Following 90 days of treatment with either OFM or OFU, both EDE and non-EDE patients improved in OSDI and VAS symptoms of dry eye disease (p<0.02), and improved or showed trends towards improvement in TBUT and staining (p<0.1). There were trends for differences in response between groups, with grittiness/foreign body sensation achieving a between-group difference in favor of the EDE group (p=0.012).

Conclusions:

In a retrospective analysis of data taken from 2 multi-center clinical trials which included a heterogeneous population of dry eye patients, 93 of 327 (28.4%) patients were classified as EDE based upon clinical criteria. When treated with dual CMC/HA polymer artificial tears for 90 days, this subgroup showed improvement in signs and symptoms of dry eye disease. Non-EDE patients also improved, with some differences between the 2 subgroups both at baseline and following treatment. This analysis supports use of these treatments in a broad cross-section of dry eye patients. FINANCIAL DISCLOUSRE: One or more of the authors is employed by a for-profit company with an interest in the subject of the presentation

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