Abstract
Purpose This randomized, observer-masked, crossover study investigated the effect of two hyaluronic acid/trehalose-based containing formulations, with different physical properties, on the signs and symptoms in patients with moderate to severe dry eye disease (DED). Methods In one group, patients received a mixture of sodium hyaluronate and trehalose (HT, Thealoz Duo®) for use during the day. In the other group, patients received a more viscous formulation consisting of hyaluronic acid, trehalose, and carbomer (HTC-gel, Thealoz Duo Gel) to use pro re nata. Both groups used HTC-gel before going to bed. Clinical standard tests for DED were performed at the beginning and end of each one-week period. Further, patient satisfaction including quality of sleep was assessed using a visual analogue scale. Results Corneal fluorescein and conjunctival lissamine green staining scores decreased, and tear breakup time (BUT) increased for both groups (p < 0.001 each). Mean instillation frequency was 3.1 ± 2.6 drops/day when using HT and 1.9 ± 2.2 drops/day when using HTC-gel (p=0.02). A significant improvement in the quality of sleep was observed with both treatments (p=0.01). Conclusions Our results show improvement in signs and symptoms of DED in both groups. While instillation of HTC-gel resulted in a lower instillation frequency, both formulations of trehalose showed good clinical efficacy. This trial is registered with NCT02980913.
Highlights
Dry eye disease (DED) is a frequent ocular disorder occurring especially in the elderly [1]
A total of 45 patients with dry eye disease aged between 20 and 72 years were included, of which 40 completed the study according to the protocol
A signi cant decrease in lissamine green staining scores was observed in both groups after one week of treatment (p < 0.001)
Summary
Dry eye disease (DED) is a frequent ocular disorder occurring especially in the elderly [1]. DED affects both the tears and the ocular surface and may produce symptoms that range from slight ocular discomfort up to a considerable reduction of quality of life caused by corneal damage, decreased vision, and pain [2, 3]. In recent years important progress has been made in the understanding of DED and its pathogenesis, tear supplementation is still a mainstay of therapy for DED. Most tear supplements function as topical lubricants and are designed to moisten the ocular surface. Trehalose, a potent osmo- and bioprotectant [6, 7], and castor oil [8, 9] have been introduced to tear supplements to exert biological effects beyond lubrication.
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