Effect of hyaluronic acid/trehalose in two different formulations on signs and symptoms in patients with moderate to severe dry eye disease

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...

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Main Authors: Fondi, Klemens, Wozniak, Piotr A., Schmidl, Doreen, Bata, Ahmed M., Witkowska, Katarzyna J., Popa-Cherecheanu, Alina, Schmetterer, Leopold, Garhöfer, Gerhard
Other Authors: Lee Kong Chian School of Medicine (LKCMedicine)
Format: Journal Article
Language:English
Published: 2018
Subjects:
Online Access:https://hdl.handle.net/10356/88982
http://hdl.handle.net/10220/46031
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author Fondi, Klemens
Wozniak, Piotr A.
Schmidl, Doreen
Bata, Ahmed M.
Witkowska, Katarzyna J.
Popa-Cherecheanu, Alina
Schmetterer, Leopold
Garhöfer, Gerhard
author2 Lee Kong Chian School of Medicine (LKCMedicine)
author_facet Lee Kong Chian School of Medicine (LKCMedicine)
Fondi, Klemens
Wozniak, Piotr A.
Schmidl, Doreen
Bata, Ahmed M.
Witkowska, Katarzyna J.
Popa-Cherecheanu, Alina
Schmetterer, Leopold
Garhöfer, Gerhard
author_sort Fondi, Klemens
collection NTU
description 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.
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spelling ntu-10356/889822020-11-01T05:10:25Z Effect of hyaluronic acid/trehalose in two different formulations on signs and symptoms in patients with moderate to severe dry eye disease Fondi, Klemens Wozniak, Piotr A. Schmidl, Doreen Bata, Ahmed M. Witkowska, Katarzyna J. Popa-Cherecheanu, Alina Schmetterer, Leopold Garhöfer, Gerhard Lee Kong Chian School of Medicine (LKCMedicine) DRNTU::Science::Medicine Hyaluronic Acid Treatment Regimens 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. Published version 2018-09-19T06:11:55Z 2019-12-06T17:15:12Z 2018-09-19T06:11:55Z 2019-12-06T17:15:12Z 2018 Journal Article Fondi, K., Wozniak, P. A., Schmidl, D., Bata, A. M., Witkowska, K. J., Popa-Cherecheanu, A., . . . Garhöfer, G. (2018). Effect of Hyaluronic Acid/Trehalose in Two Different Formulations on Signs and Symptoms in Patients with Moderate to Severe Dry Eye Disease. Journal of Ophthalmology, 2018, 4691417-. doi:10.1155/2018/4691417 2090-004X https://hdl.handle.net/10356/88982 http://hdl.handle.net/10220/46031 10.1155/2018/4691417 en Journal of Ophthalmology © 2018 Klemens Fondi et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 7 p. application/pdf
spellingShingle DRNTU::Science::Medicine
Hyaluronic Acid
Treatment Regimens
Fondi, Klemens
Wozniak, Piotr A.
Schmidl, Doreen
Bata, Ahmed M.
Witkowska, Katarzyna J.
Popa-Cherecheanu, Alina
Schmetterer, Leopold
Garhöfer, Gerhard
Effect of hyaluronic acid/trehalose in two different formulations on signs and symptoms in patients with moderate to severe dry eye disease
title Effect of hyaluronic acid/trehalose in two different formulations on signs and symptoms in patients with moderate to severe dry eye disease
title_full Effect of hyaluronic acid/trehalose in two different formulations on signs and symptoms in patients with moderate to severe dry eye disease
title_fullStr Effect of hyaluronic acid/trehalose in two different formulations on signs and symptoms in patients with moderate to severe dry eye disease
title_full_unstemmed Effect of hyaluronic acid/trehalose in two different formulations on signs and symptoms in patients with moderate to severe dry eye disease
title_short Effect of hyaluronic acid/trehalose in two different formulations on signs and symptoms in patients with moderate to severe dry eye disease
title_sort effect of hyaluronic acid trehalose in two different formulations on signs and symptoms in patients with moderate to severe dry eye disease
topic DRNTU::Science::Medicine
Hyaluronic Acid
Treatment Regimens
url https://hdl.handle.net/10356/88982
http://hdl.handle.net/10220/46031
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