Comparative study of 0.1% hyaluronic acid versus 0.5% carboxymethylcellulose in patients with dry eye associated with moderate keratitis or keratoconjunctivitis

Dorothea Groß,1 Marc Childs,2 Jean-Marie Piaton3 1Ursapharm Arzneimittel GmbH, Saarbrücken, Germany; 2Laboratoires Delbert, Paris, 3Ophthalmologic Practice, Domont, France Background: Eye drops containing 0.1% hyaluronic acid (HA) and 0.5% carboxymethylcellulose (CMC) applied on...

Descripción completa

Guardado en:

Detalles Bibliográficos
Autores principales:	Groß D, Childs M, Piaton JM
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2018
Materias:	Hyaluronate carboxymethylcellulose eye drops fluorescein lissamine green. Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/41c36240bfa84479bf2c0b7baf1890c1
Etiquetas:	Agregar Etiqueta Sin Etiquetas, Sea el primero en etiquetar este registro!

id	oai:doaj.org-article:41c36240bfa84479bf2c0b7baf1890c1
record_format	dspace
spelling	oai:doaj.org-article:41c36240bfa84479bf2c0b7baf1890c12021-12-02T03:54:12ZComparative study of 0.1% hyaluronic acid versus 0.5% carboxymethylcellulose in patients with dry eye associated with moderate keratitis or keratoconjunctivitis1177-5483https://doaj.org/article/41c36240bfa84479bf2c0b7baf1890c12018-06-01T00:00:00Zhttps://www.dovepress.com/comparative-study-of-01-hyaluronic-acid-versus-05-carboxymethylcellulo-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, 3Ophthalmologic Practice, Domont, France Background: Eye drops containing 0.1% hyaluronic acid (HA) and 0.5% carboxymethylcellulose (CMC) applied one drop three times a day per affected eye were compared in patients with moderate keratitis or keratoconjunctivitis related to dry eye disease (DED). Patients and methods: This was a prospective, randomized, multicenter, Phase IIIB noninferiority study, with a single-masked phase in parallel mode with two groups over 84 days. The primary efficacy outcome was change in ocular surface (OS) staining between day 0 (D0) and day 35 (D35). The conjunctiva and cornea were stained with lissamine green and fluorescein. Secondary efficacy measures at day 84 (D84) were OS-staining score (SS), ocular comfort index, tear-film breakup time and how patients and investigators rated treatment efficacy and safety. Results: At D35, 0.1% HA achieved a 46.6% reduction in OS-SS (-2.03±1.35 points, n=39 patients) and 0.5% CMC treatment, followed by a 34.9% reduction (-1.61±1.69 points, n=38 patients) compared to D0. At D84, the SS difference to D0 improved by -2.58±1.45 points (-59.2%) for 0.1% HA and -2.59±2.27 points (-54.4%) for 0.5% CMC. Ocular comfort-index scores improved, with significantly lower (better) values for stinging and itching on D84 for 0.1% HA. Patients assessed treatment with 0.1% HA as significantly better than 0.5% CMC (Likert scale, 4.82 vs 3.97; P=0.018). Four adverse events (AEs) occurred in four of 41 patients (9.8%) treated with 0.1% HA, and three AEs in two of 39 patients (5.1%) treated with 0.5% CMC. No serious AEs were noted. Conclusion: DED signs and symptoms of DED significantly improved with both eye drops. OS staining improved >54% at D84. Treatment was well tolerated, with only minor AEs <10%. 0.1% HA and 0.5% CMC were equally safe and effective. Significant and nonsignificant results were constantly in favor of 0.1% HA. Keywords: hyaluronate, carboxymethylcellulose, eye drops, fluorescein, lissamine greenGroß DChilds MPiaton JMDove Medical PressarticleHyaluronatecarboxymethylcelluloseeye dropsfluoresceinlissamine green.OphthalmologyRE1-994ENClinical Ophthalmology, Vol Volume 12, Pp 1081-1088 (2018)
institution	DOAJ
collection	DOAJ
language	EN
topic	Hyaluronate carboxymethylcellulose eye drops fluorescein lissamine green. Ophthalmology RE1-994
spellingShingle	Hyaluronate carboxymethylcellulose eye drops fluorescein lissamine green. Ophthalmology RE1-994 Groß D Childs M Piaton JM Comparative study of 0.1% hyaluronic acid versus 0.5% carboxymethylcellulose in patients with dry eye associated with moderate keratitis or keratoconjunctivitis
description	Dorothea Groß,1 Marc Childs,2 Jean-Marie Piaton3 1Ursapharm Arzneimittel GmbH, Saarbrücken, Germany; 2Laboratoires Delbert, Paris, 3Ophthalmologic Practice, Domont, France Background: Eye drops containing 0.1% hyaluronic acid (HA) and 0.5% carboxymethylcellulose (CMC) applied one drop three times a day per affected eye were compared in patients with moderate keratitis or keratoconjunctivitis related to dry eye disease (DED). Patients and methods: This was a prospective, randomized, multicenter, Phase IIIB noninferiority study, with a single-masked phase in parallel mode with two groups over 84 days. The primary efficacy outcome was change in ocular surface (OS) staining between day 0 (D0) and day 35 (D35). The conjunctiva and cornea were stained with lissamine green and fluorescein. Secondary efficacy measures at day 84 (D84) were OS-staining score (SS), ocular comfort index, tear-film breakup time and how patients and investigators rated treatment efficacy and safety. Results: At D35, 0.1% HA achieved a 46.6% reduction in OS-SS (-2.03±1.35 points, n=39 patients) and 0.5% CMC treatment, followed by a 34.9% reduction (-1.61±1.69 points, n=38 patients) compared to D0. At D84, the SS difference to D0 improved by -2.58±1.45 points (-59.2%) for 0.1% HA and -2.59±2.27 points (-54.4%) for 0.5% CMC. Ocular comfort-index scores improved, with significantly lower (better) values for stinging and itching on D84 for 0.1% HA. Patients assessed treatment with 0.1% HA as significantly better than 0.5% CMC (Likert scale, 4.82 vs 3.97; P=0.018). Four adverse events (AEs) occurred in four of 41 patients (9.8%) treated with 0.1% HA, and three AEs in two of 39 patients (5.1%) treated with 0.5% CMC. No serious AEs were noted. Conclusion: DED signs and symptoms of DED significantly improved with both eye drops. OS staining improved >54% at D84. Treatment was well tolerated, with only minor AEs <10%. 0.1% HA and 0.5% CMC were equally safe and effective. Significant and nonsignificant results were constantly in favor of 0.1% HA. Keywords: hyaluronate, carboxymethylcellulose, eye drops, fluorescein, lissamine green
format	article
author	Groß D Childs M Piaton JM
author_facet	Groß D Childs M Piaton JM
author_sort	Groß D
title	Comparative study of 0.1% hyaluronic acid versus 0.5% carboxymethylcellulose in patients with dry eye associated with moderate keratitis or keratoconjunctivitis
title_short	Comparative study of 0.1% hyaluronic acid versus 0.5% carboxymethylcellulose in patients with dry eye associated with moderate keratitis or keratoconjunctivitis
title_full	Comparative study of 0.1% hyaluronic acid versus 0.5% carboxymethylcellulose in patients with dry eye associated with moderate keratitis or keratoconjunctivitis
title_fullStr	Comparative study of 0.1% hyaluronic acid versus 0.5% carboxymethylcellulose in patients with dry eye associated with moderate keratitis or keratoconjunctivitis
title_full_unstemmed	Comparative study of 0.1% hyaluronic acid versus 0.5% carboxymethylcellulose in patients with dry eye associated with moderate keratitis or keratoconjunctivitis
title_sort	comparative study of 0.1% hyaluronic acid versus 0.5% carboxymethylcellulose in patients with dry eye associated with moderate keratitis or keratoconjunctivitis
publisher	Dove Medical Press
publishDate	2018
url	https://doaj.org/article/41c36240bfa84479bf2c0b7baf1890c1
work_keys_str_mv	AT großd comparativestudyof01hyaluronicacidversus05carboxymethylcelluloseinpatientswithdryeyeassociatedwithmoderatekeratitisorkeratoconjunctivitis AT childsm comparativestudyof01hyaluronicacidversus05carboxymethylcelluloseinpatientswithdryeyeassociatedwithmoderatekeratitisorkeratoconjunctivitis AT piatonjm comparativestudyof01hyaluronicacidversus05carboxymethylcelluloseinpatientswithdryeyeassociatedwithmoderatekeratitisorkeratoconjunctivitis
_version_	1718401544820359168

Comparative study of 0.1% hyaluronic acid versus 0.5% carboxymethylcellulose in patients with dry eye associated with moderate keratitis or keratoconjunctivitis

Ejemplares similares