The IMPACT study: a prospective evaluation of the effects of cyclosporine ophthalmic emulsion 0.05% on ocular surface staining and visual performance in patients with dry eye

Karl G Stonecipher,1,2 Gail L Torkildsen,3 George W Ousler III,4 Scot Morris,5 Linda Villanueva,6 David A Hollander6 1Department of Ophthalmology, University of North Carolina, Chapel Hill, 2TLC Laser Eye Centers, Greensboro, NC, 3Andover Eye Associates, 4Ora, Inc., Andover, MA, 5Eye Consultants of...

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Autores principales:	Stonecipher KG, Torkildsen GL, Ousler III GW, Morris S, Villanueva L, Hollander DA
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2016
Materias:	corneal staining cyclosporine dry eye disease ocular surface disease index ocular surface staining visual function Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/445c58ddf898415f96ad1bede45d0cea
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spelling	oai:doaj.org-article:445c58ddf898415f96ad1bede45d0cea2021-12-02T00:42:20ZThe IMPACT study: a prospective evaluation of the effects of cyclosporine ophthalmic emulsion 0.05% on ocular surface staining and visual performance in patients with dry eye1177-5483https://doaj.org/article/445c58ddf898415f96ad1bede45d0cea2016-05-01T00:00:00Zhttps://www.dovepress.com/the-impact-study-a-prospective-evaluation-of-the-effects-of-cyclospori-peer-reviewed-article-OPTHhttps://doaj.org/toc/1177-5483Karl G Stonecipher,1,2 Gail L Torkildsen,3 George W Ousler III,4 Scot Morris,5 Linda Villanueva,6 David A Hollander6 1Department of Ophthalmology, University of North Carolina, Chapel Hill, 2TLC Laser Eye Centers, Greensboro, NC, 3Andover Eye Associates, 4Ora, Inc., Andover, MA, 5Eye Consultants of Colorado, Conifer, CO, 6Allergan plc, Irvine, CA, USA Objective: The aim of this study was to evaluate the effects of cyclosporine ophthalmic emulsion 0.05% on ocular surface staining and visual performance in patients with dry eye.Methods: This was a single-center, 6-month, open-label, Phase IV study. Patients with bilateral dry eye disease and a symptom score of ≥2 on the Ocular Discomfort and 4-Symptom Questionnaire, an Ocular Surface Disease Index score of >12, at least one eye with Schirmer’s score <10 mm/5 minutes, and central corneal staining graded as ≥2 on the Ora Calibra™ Corneal and Conjunctival Staining Scale were enrolled. Cyclosporine ophthalmic emulsion 0.05% (Restasis®) was instilled twice daily in each eye. The primary efficacy endpoints were ocular surface staining and visual function at 6 months. Secondary outcome measures included Schirmer’s test, tear film breakup time, symptoms, and adverse events.Results: A total of 40 patients with the mean age of 59.4 years (range, 40–78 years) were enrolled; 35 (87.5%) were female and 37 (92.5%) completed the study. At 6 months, inferior corneal, central corneal, total corneal, and total ocular surface fluorescein staining were significantly improved from baseline in both eyes (P<0.001). Patient responses on the Ocular Surface Disease Index showed significant improvement in blurred vision and visual function related to reading, driving at night, working with a computer or bank machine, and watching television (P≤0.041). At 6 months, 35.1% of patients achieved ≥5 mm improvement and 18.9% achieved ≥10 mm improvement in the average eye Schirmer score. Mean tear film breakup time improved by >50% in both eyes (P<0.001). Patients reported significant improvement in ocular discomfort and dry eye symptoms (P<0.001). No patients discontinued treatment because of stinging or any other ocular adverse event.Conclusion: Dry eye patients with difficulties with day-to-day visual function demonstrated improvement in both signs and symptoms of dry eye and reported improved visual function after 6 months of treatment with cyclosporine ophthalmic emulsion 0.05%. Keywords: corneal staining, dry eye disease, Ocular Surface Disease Index, ocular surface staining, visual function, clinical trialStonecipher KGTorkildsen GLOusler III GWMorris SVillanueva LHollander DADove Medical Pressarticlecorneal stainingcyclosporinedry eye diseaseocular surface disease indexocular surface stainingvisual functionOphthalmologyRE1-994ENClinical Ophthalmology, Vol 2016, Iss Issue 1, Pp 887-895 (2016)
institution	DOAJ
collection	DOAJ
language	EN
topic	corneal staining cyclosporine dry eye disease ocular surface disease index ocular surface staining visual function Ophthalmology RE1-994
spellingShingle	corneal staining cyclosporine dry eye disease ocular surface disease index ocular surface staining visual function Ophthalmology RE1-994 Stonecipher KG Torkildsen GL Ousler III GW Morris S Villanueva L Hollander DA The IMPACT study: a prospective evaluation of the effects of cyclosporine ophthalmic emulsion 0.05% on ocular surface staining and visual performance in patients with dry eye
description	Karl G Stonecipher,1,2 Gail L Torkildsen,3 George W Ousler III,4 Scot Morris,5 Linda Villanueva,6 David A Hollander6 1Department of Ophthalmology, University of North Carolina, Chapel Hill, 2TLC Laser Eye Centers, Greensboro, NC, 3Andover Eye Associates, 4Ora, Inc., Andover, MA, 5Eye Consultants of Colorado, Conifer, CO, 6Allergan plc, Irvine, CA, USA Objective: The aim of this study was to evaluate the effects of cyclosporine ophthalmic emulsion 0.05% on ocular surface staining and visual performance in patients with dry eye.Methods: This was a single-center, 6-month, open-label, Phase IV study. Patients with bilateral dry eye disease and a symptom score of ≥2 on the Ocular Discomfort and 4-Symptom Questionnaire, an Ocular Surface Disease Index score of >12, at least one eye with Schirmer’s score <10 mm/5 minutes, and central corneal staining graded as ≥2 on the Ora Calibra™ Corneal and Conjunctival Staining Scale were enrolled. Cyclosporine ophthalmic emulsion 0.05% (Restasis®) was instilled twice daily in each eye. The primary efficacy endpoints were ocular surface staining and visual function at 6 months. Secondary outcome measures included Schirmer’s test, tear film breakup time, symptoms, and adverse events.Results: A total of 40 patients with the mean age of 59.4 years (range, 40–78 years) were enrolled; 35 (87.5%) were female and 37 (92.5%) completed the study. At 6 months, inferior corneal, central corneal, total corneal, and total ocular surface fluorescein staining were significantly improved from baseline in both eyes (P<0.001). Patient responses on the Ocular Surface Disease Index showed significant improvement in blurred vision and visual function related to reading, driving at night, working with a computer or bank machine, and watching television (P≤0.041). At 6 months, 35.1% of patients achieved ≥5 mm improvement and 18.9% achieved ≥10 mm improvement in the average eye Schirmer score. Mean tear film breakup time improved by >50% in both eyes (P<0.001). Patients reported significant improvement in ocular discomfort and dry eye symptoms (P<0.001). No patients discontinued treatment because of stinging or any other ocular adverse event.Conclusion: Dry eye patients with difficulties with day-to-day visual function demonstrated improvement in both signs and symptoms of dry eye and reported improved visual function after 6 months of treatment with cyclosporine ophthalmic emulsion 0.05%. Keywords: corneal staining, dry eye disease, Ocular Surface Disease Index, ocular surface staining, visual function, clinical trial
format	article
author	Stonecipher KG Torkildsen GL Ousler III GW Morris S Villanueva L Hollander DA
author_facet	Stonecipher KG Torkildsen GL Ousler III GW Morris S Villanueva L Hollander DA
author_sort	Stonecipher KG
title	The IMPACT study: a prospective evaluation of the effects of cyclosporine ophthalmic emulsion 0.05% on ocular surface staining and visual performance in patients with dry eye
title_short	The IMPACT study: a prospective evaluation of the effects of cyclosporine ophthalmic emulsion 0.05% on ocular surface staining and visual performance in patients with dry eye
title_full	The IMPACT study: a prospective evaluation of the effects of cyclosporine ophthalmic emulsion 0.05% on ocular surface staining and visual performance in patients with dry eye
title_fullStr	The IMPACT study: a prospective evaluation of the effects of cyclosporine ophthalmic emulsion 0.05% on ocular surface staining and visual performance in patients with dry eye
title_full_unstemmed	The IMPACT study: a prospective evaluation of the effects of cyclosporine ophthalmic emulsion 0.05% on ocular surface staining and visual performance in patients with dry eye
title_sort	impact study: a prospective evaluation of the effects of cyclosporine ophthalmic emulsion 0.05% on ocular surface staining and visual performance in patients with dry eye
publisher	Dove Medical Press
publishDate	2016
url	https://doaj.org/article/445c58ddf898415f96ad1bede45d0cea
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The IMPACT study: a prospective evaluation of the effects of cyclosporine ophthalmic emulsion 0.05% on ocular surface staining and visual performance in patients with dry eye

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