Safety and Efficacy of a Preservative-Free Artificial Tear Containing Carboxymethylcellulose and Hyaluronic Acid for Dry Eye Disease: A Randomized, Controlled, Multicenter 3-Month Study

Pasquale Aragona,1 Jose M Benítez-del-Castillo,2 Minas T Coroneo,3 Subhanjan Mukherji,4 Jacqueline Tan,5 Evelien Vandewalle,6 Algis Vingrys,7 Haixia Liu,8 Cindy Carlisle-Wilcox,8 Joseph Vehige,8 Peter A Simmons5,8 1Department of Biomedical Sciences, Università di Messina, Messi...

Descripción completa

Guardado en:

Detalles Bibliográficos
Autores principales:	Aragona P, Benítez-del-Castillo JM, Coroneo MT, Mukherji S, Tan J, Vandewalle E, Vingrys A, Liu H, Carlisle-Wilcox C, Vehige J, Simmons PA
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2020
Materias:	carboxymethylcellulose hyaluronic acid artificial tears dry eye Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/319a28cfe3d3431cb107459653373ad6
Etiquetas:	Agregar Etiqueta Sin Etiquetas, Sea el primero en etiquetar este registro!

id	oai:doaj.org-article:319a28cfe3d3431cb107459653373ad6
record_format	dspace
spelling	oai:doaj.org-article:319a28cfe3d3431cb107459653373ad62021-12-02T11:07:11ZSafety and Efficacy of a Preservative-Free Artificial Tear Containing Carboxymethylcellulose and Hyaluronic Acid for Dry Eye Disease: A Randomized, Controlled, Multicenter 3-Month Study1177-5483https://doaj.org/article/319a28cfe3d3431cb107459653373ad62020-10-01T00:00:00Zhttps://www.dovepress.com/safety-and-efficacy-of-a-preservative-free-artificial-tear-containing--peer-reviewed-article-OPTHhttps://doaj.org/toc/1177-5483Pasquale Aragona,1 Jose M Benítez-del-Castillo,2 Minas T Coroneo,3 Subhanjan Mukherji,4 Jacqueline Tan,5 Evelien Vandewalle,6 Algis Vingrys,7 Haixia Liu,8 Cindy Carlisle-Wilcox,8 Joseph Vehige,8 Peter A Simmons5,8 1Department of Biomedical Sciences, Università di Messina, Messina, Italy; 2Department of Ophthalmology, Hospital Clinico de Madrid, Universidad Complutense, Madrid, Spain; 3M.T. Coroneo Pty. Ltd, Randwick, NSW, Australia; 4Department of Ophthalmology, James Paget University Hospital, Great Yarmouth, UK; 5Optometry and Vision Science, UNSW Sydney, Sydney, NSW, Australia; 6Department of Ophthalmology, University Hospitals Leuven, Leuven, Belgium; 7University of Melbourne EyeCare Clinic, Carlton, VIC, Australia; 8Allergan, an AbbVie company, Irvine, CA, USACorrespondence: Peter A SimmonsPCS Research, 16611 Camille Place, Yorba Linda, CA, USATel + 1-714-743-3352Email pasimmons17@gmail.comPurpose: To compare the efficacy and safety of an artificial tear combining the polymers carboxymethylcellulose (CMC) and hyaluronic acid (HA), to a formulation of CMC alone in subjects with dry eye.Methods: A preservative-free artificial tear (CMC-HA) was compared with an existing artificial tear (CMC). Subjects with mild-to-severe signs and symptoms of dry eye were enrolled in this double-masked, randomized, multicenter trial, and dosed at least twice daily for 90 days, with follow-up visits at Days 7, 30, 60, and 90. Ocular Surface Disease Index (OSDI) was the primary outcome measure. Secondary outcome measures were tear break-up time (TBUT), ocular surface staining, Schirmer test with anesthesia, and visual analog scale (VAS) scores of dry eye symptom severity and formulation acceptability. Safety measures included adverse events, biomicroscopy, and visual acuity.Results: A total of 460 subjects were enrolled across 45 sites (38 in Europe; 7 in Australia), of whom 454 were randomized to receive treatment. The per-protocol (PP) population consisted of 394 subjects, 364 (92.4%) of whom completed the study. In the PP population, the mean ± SD change from baseline in OSDI score at the primary timepoint, Day 90, was − 16.9± 17.5 for CMC-HA and − 16.0± 16.1 for CMC. CMC-HA was non-inferior to CMC based upon a confidence interval method. Both treatments significantly improved (P< 0.001) OSDI, symptom VAS scores, TBUT, and ocular surface staining from baseline at all follow-up visits, with minimal differences between groups. Greater reduction of overall ocular pain/discomfort was reported in subjects using CMC-HA versus CMC (P=0.048). Approximately 10% of subjects in each group reported treatment-related adverse events of generally mild to moderate severity.Conclusion: The new CMC-HA formulation was effective and well tolerated, and demonstrates a greater potential for symptom relief compared with CMC. These data support implementation of this formula for the management of dry eye patients.Keywords: carboxymethylcellulose, hyaluronic acid, artificial tears, dry eyeAragona PBenítez-del-Castillo JMCoroneo MTMukherji STan JVandewalle EVingrys ALiu HCarlisle-Wilcox CVehige JSimmons PADove Medical Pressarticlecarboxymethylcellulosehyaluronic acidartificial tearsdry eyeOphthalmologyRE1-994ENClinical Ophthalmology, Vol Volume 14, Pp 2951-2963 (2020)
institution	DOAJ
collection	DOAJ
language	EN
topic	carboxymethylcellulose hyaluronic acid artificial tears dry eye Ophthalmology RE1-994
spellingShingle	carboxymethylcellulose hyaluronic acid artificial tears dry eye Ophthalmology RE1-994 Aragona P Benítez-del-Castillo JM Coroneo MT Mukherji S Tan J Vandewalle E Vingrys A Liu H Carlisle-Wilcox C Vehige J Simmons PA Safety and Efficacy of a Preservative-Free Artificial Tear Containing Carboxymethylcellulose and Hyaluronic Acid for Dry Eye Disease: A Randomized, Controlled, Multicenter 3-Month Study
description	Pasquale Aragona,1 Jose M Benítez-del-Castillo,2 Minas T Coroneo,3 Subhanjan Mukherji,4 Jacqueline Tan,5 Evelien Vandewalle,6 Algis Vingrys,7 Haixia Liu,8 Cindy Carlisle-Wilcox,8 Joseph Vehige,8 Peter A Simmons5,8 1Department of Biomedical Sciences, Università di Messina, Messina, Italy; 2Department of Ophthalmology, Hospital Clinico de Madrid, Universidad Complutense, Madrid, Spain; 3M.T. Coroneo Pty. Ltd, Randwick, NSW, Australia; 4Department of Ophthalmology, James Paget University Hospital, Great Yarmouth, UK; 5Optometry and Vision Science, UNSW Sydney, Sydney, NSW, Australia; 6Department of Ophthalmology, University Hospitals Leuven, Leuven, Belgium; 7University of Melbourne EyeCare Clinic, Carlton, VIC, Australia; 8Allergan, an AbbVie company, Irvine, CA, USACorrespondence: Peter A SimmonsPCS Research, 16611 Camille Place, Yorba Linda, CA, USATel + 1-714-743-3352Email pasimmons17@gmail.comPurpose: To compare the efficacy and safety of an artificial tear combining the polymers carboxymethylcellulose (CMC) and hyaluronic acid (HA), to a formulation of CMC alone in subjects with dry eye.Methods: A preservative-free artificial tear (CMC-HA) was compared with an existing artificial tear (CMC). Subjects with mild-to-severe signs and symptoms of dry eye were enrolled in this double-masked, randomized, multicenter trial, and dosed at least twice daily for 90 days, with follow-up visits at Days 7, 30, 60, and 90. Ocular Surface Disease Index (OSDI) was the primary outcome measure. Secondary outcome measures were tear break-up time (TBUT), ocular surface staining, Schirmer test with anesthesia, and visual analog scale (VAS) scores of dry eye symptom severity and formulation acceptability. Safety measures included adverse events, biomicroscopy, and visual acuity.Results: A total of 460 subjects were enrolled across 45 sites (38 in Europe; 7 in Australia), of whom 454 were randomized to receive treatment. The per-protocol (PP) population consisted of 394 subjects, 364 (92.4%) of whom completed the study. In the PP population, the mean ± SD change from baseline in OSDI score at the primary timepoint, Day 90, was − 16.9± 17.5 for CMC-HA and − 16.0± 16.1 for CMC. CMC-HA was non-inferior to CMC based upon a confidence interval method. Both treatments significantly improved (P< 0.001) OSDI, symptom VAS scores, TBUT, and ocular surface staining from baseline at all follow-up visits, with minimal differences between groups. Greater reduction of overall ocular pain/discomfort was reported in subjects using CMC-HA versus CMC (P=0.048). Approximately 10% of subjects in each group reported treatment-related adverse events of generally mild to moderate severity.Conclusion: The new CMC-HA formulation was effective and well tolerated, and demonstrates a greater potential for symptom relief compared with CMC. These data support implementation of this formula for the management of dry eye patients.Keywords: carboxymethylcellulose, hyaluronic acid, artificial tears, dry eye
format	article
author	Aragona P Benítez-del-Castillo JM Coroneo MT Mukherji S Tan J Vandewalle E Vingrys A Liu H Carlisle-Wilcox C Vehige J Simmons PA
author_facet	Aragona P Benítez-del-Castillo JM Coroneo MT Mukherji S Tan J Vandewalle E Vingrys A Liu H Carlisle-Wilcox C Vehige J Simmons PA
author_sort	Aragona P
title	Safety and Efficacy of a Preservative-Free Artificial Tear Containing Carboxymethylcellulose and Hyaluronic Acid for Dry Eye Disease: A Randomized, Controlled, Multicenter 3-Month Study
title_short	Safety and Efficacy of a Preservative-Free Artificial Tear Containing Carboxymethylcellulose and Hyaluronic Acid for Dry Eye Disease: A Randomized, Controlled, Multicenter 3-Month Study
title_full	Safety and Efficacy of a Preservative-Free Artificial Tear Containing Carboxymethylcellulose and Hyaluronic Acid for Dry Eye Disease: A Randomized, Controlled, Multicenter 3-Month Study
title_fullStr	Safety and Efficacy of a Preservative-Free Artificial Tear Containing Carboxymethylcellulose and Hyaluronic Acid for Dry Eye Disease: A Randomized, Controlled, Multicenter 3-Month Study
title_full_unstemmed	Safety and Efficacy of a Preservative-Free Artificial Tear Containing Carboxymethylcellulose and Hyaluronic Acid for Dry Eye Disease: A Randomized, Controlled, Multicenter 3-Month Study
title_sort	safety and efficacy of a preservative-free artificial tear containing carboxymethylcellulose and hyaluronic acid for dry eye disease: a randomized, controlled, multicenter 3-month study
publisher	Dove Medical Press
publishDate	2020
url	https://doaj.org/article/319a28cfe3d3431cb107459653373ad6
work_keys_str_mv	AT aragonap safetyandefficacyofapreservativefreeartificialtearcontainingcarboxymethylcelluloseandhyaluronicacidfordryeyediseasearandomizedcontrolledmulticenter3monthstudy AT benitezdelcastillojm safetyandefficacyofapreservativefreeartificialtearcontainingcarboxymethylcelluloseandhyaluronicacidfordryeyediseasearandomizedcontrolledmulticenter3monthstudy AT coroneomt safetyandefficacyofapreservativefreeartificialtearcontainingcarboxymethylcelluloseandhyaluronicacidfordryeyediseasearandomizedcontrolledmulticenter3monthstudy AT mukherjis safetyandefficacyofapreservativefreeartificialtearcontainingcarboxymethylcelluloseandhyaluronicacidfordryeyediseasearandomizedcontrolledmulticenter3monthstudy AT tanj safetyandefficacyofapreservativefreeartificialtearcontainingcarboxymethylcelluloseandhyaluronicacidfordryeyediseasearandomizedcontrolledmulticenter3monthstudy AT vandewallee safetyandefficacyofapreservativefreeartificialtearcontainingcarboxymethylcelluloseandhyaluronicacidfordryeyediseasearandomizedcontrolledmulticenter3monthstudy AT vingrysa safetyandefficacyofapreservativefreeartificialtearcontainingcarboxymethylcelluloseandhyaluronicacidfordryeyediseasearandomizedcontrolledmulticenter3monthstudy AT liuh safetyandefficacyofapreservativefreeartificialtearcontainingcarboxymethylcelluloseandhyaluronicacidfordryeyediseasearandomizedcontrolledmulticenter3monthstudy AT carlislewilcoxc safetyandefficacyofapreservativefreeartificialtearcontainingcarboxymethylcelluloseandhyaluronicacidfordryeyediseasearandomizedcontrolledmulticenter3monthstudy AT vehigej safetyandefficacyofapreservativefreeartificialtearcontainingcarboxymethylcelluloseandhyaluronicacidfordryeyediseasearandomizedcontrolledmulticenter3monthstudy AT simmonspa safetyandefficacyofapreservativefreeartificialtearcontainingcarboxymethylcelluloseandhyaluronicacidfordryeyediseasearandomizedcontrolledmulticenter3monthstudy
_version_	1718396219841052672

Safety and Efficacy of a Preservative-Free Artificial Tear Containing Carboxymethylcellulose and Hyaluronic Acid for Dry Eye Disease: A Randomized, Controlled, Multicenter 3-Month Study

Ejemplares similares