Comparison of 0.2% and 0.18% hyaluronate eye drops in patients with moderate to severe dry eye with keratitis or keratoconjunctivitis

Dorothea Groß,1 Marc Childs,2 Jean-Marie Piaton3 1Ursapharm Arzneimittel GmbH, Saarbrücken, Germany; 2Laboratoires Delbert, Paris, 3Ophthalmic Practice, Domont, France Purpose: Comparison of efficacy and safety of 0.2% and 0.18% hyaluronic acid (HA) eye drops three times a day (...

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Autores principales:	Groß D, Childs M, Piaton J
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2017
Materias:	Dry eye hyaluronic acid ocular surface lesions ocular staining keratoconjunctivitis sicca Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/fa34ae3f6fab40f19d4ae5e588804afe
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spelling	oai:doaj.org-article:fa34ae3f6fab40f19d4ae5e588804afe2021-12-02T01:43:11ZComparison of 0.2% and 0.18% hyaluronate eye drops in patients with moderate to severe dry eye with keratitis or keratoconjunctivitis1177-5483https://doaj.org/article/fa34ae3f6fab40f19d4ae5e588804afe2017-04-01T00:00:00Zhttps://www.dovepress.com/comparison-of-02-and-018-hyaluronate-eye-drops-in-patients-with-modera-peer-reviewed-article-OPTHhttps://doaj.org/toc/1177-5483Dorothea Groß,1 Marc Childs,2 Jean-Marie Piaton3 1Ursapharm Arzneimittel GmbH, Saarbrücken, Germany; 2Laboratoires Delbert, Paris, 3Ophthalmic Practice, Domont, France Purpose: Comparison of efficacy and safety of 0.2% and 0.18% hyaluronic acid (HA) eye drops three times a day (tid) in patients with moderate to severe dry eye disease, related to keratitis or keratoconjunctivitis. Patients and methods: Prospective, multicenter, randomized, single-masked, phase IIIb, noninferiority study (0.2% HA vs 0.18% HA) in two parallel groups over a period of 84 days. N=70 patients were evaluated. Primary efficacy outcome was ocular surface (OS) staining change on day 35 (D35), compared to baseline. Fluorescein and lissamine green were used for staining of cornea and conjunctiva. Secondary efficacy outcome included tear film breakup time, OS staining score on day 84 (D84), ocular comfort index, as well as patients’ and doctors’ evaluation. Results: Compared to day 0 (D0), 0.2% HA achieved a 47.7% reduction in staining score (-3.00±2.81 [standard deviation] points, n=38 patients) at D35; 0.18% HA showed a 41.2% reduction (-2.59±2.20 [standard deviation] points, n=32 patients). Statistical analysis showed noninferiority in efficacy of 0.2% HA compared to 0.18% HA on D35. At D84, the reduction in staining score had further increased to 64.5% for 0.2% HA and to 56.4% for 0.18% HA. Both eye drops improved tear film breakup time and ocular comfort index values. Investigators and patients assessed both treatments with 5 of 7 points (Likert Scale, medians). The rate of adverse events (AE) was 2.3% for 0.2% HA and 7.1% for 0.18% HA with no serious AE. Conclusion: 0.2% and 0.18% HA eye drops significantly improved signs and symptoms of dry eye disease and were well tolerated with few AEs. Noninferiority of 0.2% HA compared to 0.18% HA was demonstrated for reduction of OS lesions. In some parameters, there was a nonsignificant trend in favor of 0.2% HA concentration. Keywords: dry eye, hyaluronic acid, ocular surface lesions, ocular staining, keratoconjunctivitis sicca, eye drops, unpreserved, hyaluronate, fluorescein, lissamine greenGroß DChilds MPiaton JDove Medical PressarticleDry eyehyaluronic acidocular surface lesionsocular stainingkeratoconjunctivitis siccaOphthalmologyRE1-994ENClinical Ophthalmology, Vol Volume 11, Pp 631-638 (2017)
institution	DOAJ
collection	DOAJ
language	EN
topic	Dry eye hyaluronic acid ocular surface lesions ocular staining keratoconjunctivitis sicca Ophthalmology RE1-994
spellingShingle	Dry eye hyaluronic acid ocular surface lesions ocular staining keratoconjunctivitis sicca Ophthalmology RE1-994 Groß D Childs M Piaton J Comparison of 0.2% and 0.18% hyaluronate eye drops in patients with moderate to severe dry eye with keratitis or keratoconjunctivitis
description	Dorothea Groß,1 Marc Childs,2 Jean-Marie Piaton3 1Ursapharm Arzneimittel GmbH, Saarbrücken, Germany; 2Laboratoires Delbert, Paris, 3Ophthalmic Practice, Domont, France Purpose: Comparison of efficacy and safety of 0.2% and 0.18% hyaluronic acid (HA) eye drops three times a day (tid) in patients with moderate to severe dry eye disease, related to keratitis or keratoconjunctivitis. Patients and methods: Prospective, multicenter, randomized, single-masked, phase IIIb, noninferiority study (0.2% HA vs 0.18% HA) in two parallel groups over a period of 84 days. N=70 patients were evaluated. Primary efficacy outcome was ocular surface (OS) staining change on day 35 (D35), compared to baseline. Fluorescein and lissamine green were used for staining of cornea and conjunctiva. Secondary efficacy outcome included tear film breakup time, OS staining score on day 84 (D84), ocular comfort index, as well as patients’ and doctors’ evaluation. Results: Compared to day 0 (D0), 0.2% HA achieved a 47.7% reduction in staining score (-3.00±2.81 [standard deviation] points, n=38 patients) at D35; 0.18% HA showed a 41.2% reduction (-2.59±2.20 [standard deviation] points, n=32 patients). Statistical analysis showed noninferiority in efficacy of 0.2% HA compared to 0.18% HA on D35. At D84, the reduction in staining score had further increased to 64.5% for 0.2% HA and to 56.4% for 0.18% HA. Both eye drops improved tear film breakup time and ocular comfort index values. Investigators and patients assessed both treatments with 5 of 7 points (Likert Scale, medians). The rate of adverse events (AE) was 2.3% for 0.2% HA and 7.1% for 0.18% HA with no serious AE. Conclusion: 0.2% and 0.18% HA eye drops significantly improved signs and symptoms of dry eye disease and were well tolerated with few AEs. Noninferiority of 0.2% HA compared to 0.18% HA was demonstrated for reduction of OS lesions. In some parameters, there was a nonsignificant trend in favor of 0.2% HA concentration. Keywords: dry eye, hyaluronic acid, ocular surface lesions, ocular staining, keratoconjunctivitis sicca, eye drops, unpreserved, hyaluronate, fluorescein, lissamine green
format	article
author	Groß D Childs M Piaton J
author_facet	Groß D Childs M Piaton J
author_sort	Groß D
title	Comparison of 0.2% and 0.18% hyaluronate eye drops in patients with moderate to severe dry eye with keratitis or keratoconjunctivitis
title_short	Comparison of 0.2% and 0.18% hyaluronate eye drops in patients with moderate to severe dry eye with keratitis or keratoconjunctivitis
title_full	Comparison of 0.2% and 0.18% hyaluronate eye drops in patients with moderate to severe dry eye with keratitis or keratoconjunctivitis
title_fullStr	Comparison of 0.2% and 0.18% hyaluronate eye drops in patients with moderate to severe dry eye with keratitis or keratoconjunctivitis
title_full_unstemmed	Comparison of 0.2% and 0.18% hyaluronate eye drops in patients with moderate to severe dry eye with keratitis or keratoconjunctivitis
title_sort	comparison of 0.2% and 0.18% hyaluronate eye drops in patients with moderate to severe dry eye with keratitis or keratoconjunctivitis
publisher	Dove Medical Press
publishDate	2017
url	https://doaj.org/article/fa34ae3f6fab40f19d4ae5e588804afe
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Comparison of 0.2% and 0.18% hyaluronate eye drops in patients with moderate to severe dry eye with keratitis or keratoconjunctivitis

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