Effect of Hyaluronic AcidTrehalose in Two Different Formulations on Signs and Symptoms in Patients with Moderate to Severe Dry Eye Disease

الملخص EN

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.