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

Klemens Fondi, Piotr A Wozniak, Doreen Schmidl, Ahmed M Bata, Katarzyna J Witkowska, Alina Popa-Cherecheanu, Leopold Schmetterer, Gerhard Garhöfer, Klemens Fondi, Piotr A Wozniak, Doreen Schmidl, Ahmed M Bata, Katarzyna J Witkowska, Alina Popa-Cherecheanu, Leopold Schmetterer, Gerhard Garhöfer

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.

Figures

Figure 1
Figure 1
Randomization process and study design.
Figure 2
Figure 2
Divisions of the cornea according to the NEI/Industry Workshop guidelines [15].
Figure 3
Figure 3
Difference in the frequency of use when using a gel containing hyaluronic acid, trehalose, and carbomer (HTC-gel) PRN compared to using eye drops containing hyaluronic acid and trehalose (HT) PRN.
Figure 4
Figure 4
Patients' quality of sleep on the VAS at baseline and after one-week treatment with a gel containing hyaluronic acid, trehalose, and carbomer (HTC-gel) PRN compared to using eye drops containing hyaluronic acid and trehalose (HT) PRN.

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