Management of post-LASIK dry eye: a multicenter randomized comparison of a new multi-ingredient artificial tear to carboxymethylcellulose

Avi Wallerstein,1,2 W Bruce Jackson,3 Jeffrey Chambers,4 Amir M Moezzi,5 Hugh Lin,6 Peter A Simmons6 1Department of Ophthalmology, McGill University, Montreal, QC, Canada; 2LASIK MD, Montreal, QC, Canada; 3University of Ottawa Eye Institute of the Ottawa Hospital, Ottawa, ON, Canada; 4Kelowna Eye C...

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Autores principales:	Wallerstein A, Jackson WB, Chambers J, Moezzi AM, Lin H, Simmons PA
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2018
Materias:	post-LASIK dry eye artificial tears carboxymethylcellulose hyaluronic acid Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/220e4674f48d4bfda0e99b361629f42b
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spelling	oai:doaj.org-article:220e4674f48d4bfda0e99b361629f42b2021-12-02T00:57:21ZManagement of post-LASIK dry eye: a multicenter randomized comparison of a new multi-ingredient artificial tear to carboxymethylcellulose1177-5483https://doaj.org/article/220e4674f48d4bfda0e99b361629f42b2018-05-01T00:00:00Zhttps://www.dovepress.com/management-of-post-lasik-dry-eye-a-multicenter-randomized-comparison-o-peer-reviewed-article-OPTHhttps://doaj.org/toc/1177-5483Avi Wallerstein,1,2 W Bruce Jackson,3 Jeffrey Chambers,4 Amir M Moezzi,5 Hugh Lin,6 Peter A Simmons6 1Department of Ophthalmology, McGill University, Montreal, QC, Canada; 2LASIK MD, Montreal, QC, Canada; 3University of Ottawa Eye Institute of the Ottawa Hospital, Ottawa, ON, Canada; 4Kelowna Eye Care Center, Kelowna, BC, Canada; 5Centre for Ocular Research & Education (CORE, formerly Centre for Contact Lens Research), School of Optometry & Vision Science, University of Waterloo, Waterloo, ON, Canada; 6Allergan Clinical Research, Allergan plc, Irvine, CA, USA Purpose: To compare the efficacy and safety of a preservative-free, multi-ingredient formulation of carboxymethylcellulose 0.5%, hyaluronic acid 0.1%, and organic osmolytes (CMC-HA), to preservative-free carboxymethylcellulose 0.5% (CMC) in the management of postoperative signs and symptoms of dry eye following laser-assisted in situ keratomileusis (LASIK). Methods: This was a double-masked, randomized, parallel-group study conducted in 14 clinical centers in Canada and Australia. Subjects with no more than mild dry eye instilled CMC-HA or CMC for 90 days post-LASIK. Ocular Surface Disease Index© (OSDI; primary efficacy measure), corneal staining, tear break-up time (TBUT), Schirmer’s test, acceptability/tolerability surveys, and visual acuity were assessed at screening and days 2, 10, 30, 60, and 90 post-surgery. Safety analyses included all enrolled. Results: A total of 148 subjects (CMC-HA, n=75; CMC, n=73) were enrolled and assigned to receive treatment, and 126 subjects completed the study without any protocol violations. Post-LASIK, dry eye signs/symptoms peaked at 10 days. OSDI scores for both groups returned to normal with no differences between treatment groups at day 90 (P=0.775). Corneal staining, Schirmer’s test, TBUT, and survey results were comparable. Higher mean improvements in uncorrected visual acuity were observed in the CMC-HA group at all study visits, reaching statistical significance at day 30 (P=0.013). Both treatments were well tolerated. Conclusion: CMC-HA-containing artificial tears relieved post-LASIK ocular dryness as well as CMC alone, and demonstrated incremental benefit in uncorrected vision, with a favorable safety profile. Results support use of CMC-HA eye drops to reduce signs and symptoms of ocular dryness post-LASIK. Keywords: LASIK, dry eye, artificial tears, carboxymethylcellulose, hyaluronic acid, ocular surface diseaseWallerstein AJackson WBChambers JMoezzi AMLin HSimmons PADove Medical Pressarticlepost-LASIKdry eyeartificial tearscarboxymethylcellulosehyaluronic acidOphthalmologyRE1-994ENClinical Ophthalmology, Vol Volume 12, Pp 839-848 (2018)
institution	DOAJ
collection	DOAJ
language	EN
topic	post-LASIK dry eye artificial tears carboxymethylcellulose hyaluronic acid Ophthalmology RE1-994
spellingShingle	post-LASIK dry eye artificial tears carboxymethylcellulose hyaluronic acid Ophthalmology RE1-994 Wallerstein A Jackson WB Chambers J Moezzi AM Lin H Simmons PA Management of post-LASIK dry eye: a multicenter randomized comparison of a new multi-ingredient artificial tear to carboxymethylcellulose
description	Avi Wallerstein,1,2 W Bruce Jackson,3 Jeffrey Chambers,4 Amir M Moezzi,5 Hugh Lin,6 Peter A Simmons6 1Department of Ophthalmology, McGill University, Montreal, QC, Canada; 2LASIK MD, Montreal, QC, Canada; 3University of Ottawa Eye Institute of the Ottawa Hospital, Ottawa, ON, Canada; 4Kelowna Eye Care Center, Kelowna, BC, Canada; 5Centre for Ocular Research & Education (CORE, formerly Centre for Contact Lens Research), School of Optometry & Vision Science, University of Waterloo, Waterloo, ON, Canada; 6Allergan Clinical Research, Allergan plc, Irvine, CA, USA Purpose: To compare the efficacy and safety of a preservative-free, multi-ingredient formulation of carboxymethylcellulose 0.5%, hyaluronic acid 0.1%, and organic osmolytes (CMC-HA), to preservative-free carboxymethylcellulose 0.5% (CMC) in the management of postoperative signs and symptoms of dry eye following laser-assisted in situ keratomileusis (LASIK). Methods: This was a double-masked, randomized, parallel-group study conducted in 14 clinical centers in Canada and Australia. Subjects with no more than mild dry eye instilled CMC-HA or CMC for 90 days post-LASIK. Ocular Surface Disease Index© (OSDI; primary efficacy measure), corneal staining, tear break-up time (TBUT), Schirmer’s test, acceptability/tolerability surveys, and visual acuity were assessed at screening and days 2, 10, 30, 60, and 90 post-surgery. Safety analyses included all enrolled. Results: A total of 148 subjects (CMC-HA, n=75; CMC, n=73) were enrolled and assigned to receive treatment, and 126 subjects completed the study without any protocol violations. Post-LASIK, dry eye signs/symptoms peaked at 10 days. OSDI scores for both groups returned to normal with no differences between treatment groups at day 90 (P=0.775). Corneal staining, Schirmer’s test, TBUT, and survey results were comparable. Higher mean improvements in uncorrected visual acuity were observed in the CMC-HA group at all study visits, reaching statistical significance at day 30 (P=0.013). Both treatments were well tolerated. Conclusion: CMC-HA-containing artificial tears relieved post-LASIK ocular dryness as well as CMC alone, and demonstrated incremental benefit in uncorrected vision, with a favorable safety profile. Results support use of CMC-HA eye drops to reduce signs and symptoms of ocular dryness post-LASIK. Keywords: LASIK, dry eye, artificial tears, carboxymethylcellulose, hyaluronic acid, ocular surface disease
format	article
author	Wallerstein A Jackson WB Chambers J Moezzi AM Lin H Simmons PA
author_facet	Wallerstein A Jackson WB Chambers J Moezzi AM Lin H Simmons PA
author_sort	Wallerstein A
title	Management of post-LASIK dry eye: a multicenter randomized comparison of a new multi-ingredient artificial tear to carboxymethylcellulose
title_short	Management of post-LASIK dry eye: a multicenter randomized comparison of a new multi-ingredient artificial tear to carboxymethylcellulose
title_full	Management of post-LASIK dry eye: a multicenter randomized comparison of a new multi-ingredient artificial tear to carboxymethylcellulose
title_fullStr	Management of post-LASIK dry eye: a multicenter randomized comparison of a new multi-ingredient artificial tear to carboxymethylcellulose
title_full_unstemmed	Management of post-LASIK dry eye: a multicenter randomized comparison of a new multi-ingredient artificial tear to carboxymethylcellulose
title_sort	management of post-lasik dry eye: a multicenter randomized comparison of a new multi-ingredient artificial tear to carboxymethylcellulose
publisher	Dove Medical Press
publishDate	2018
url	https://doaj.org/article/220e4674f48d4bfda0e99b361629f42b
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Management of post-LASIK dry eye: a multicenter randomized comparison of a new multi-ingredient artificial tear to carboxymethylcellulose

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