A Post-Acute Ocular Tolerability Comparison of Topical Reproxalap 0.25% and Lifitegrast 5% in Patients with Dry Eye Disease

David McMullin,1 David Clark,1 Bill Cavanagh,1 Paul Karpecki,2 Todd C Brady1 1Aldeyra Therapeutics, Inc, Lexington, MA, USA; 2Kentucky Eye Institute, Lexington, KY, USACorrespondence: Todd C BradyAldeyra Therapeutics, Inc, 131 Hartwell Avenue, Suite 320, Lexington, MA, 02421, USATel +1 781 761-4904E...

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Autores principales:	McMullin D, Clark D, Cavanagh B, Karpecki P, Brady TC
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2021
Materias:	rasp inhibitor dry eye disease inflammation reproxalap lifitegrast eye drop comfort Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/8ed6c8cfce4d4c78970537ad6781fa01
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spelling	oai:doaj.org-article:8ed6c8cfce4d4c78970537ad6781fa012021-12-02T18:48:31ZA Post-Acute Ocular Tolerability Comparison of Topical Reproxalap 0.25% and Lifitegrast 5% in Patients with Dry Eye Disease1177-5483https://doaj.org/article/8ed6c8cfce4d4c78970537ad6781fa012021-09-01T00:00:00Zhttps://www.dovepress.com/a-post-acute-ocular-tolerability-comparison-of-topical-reproxalap-025--peer-reviewed-fulltext-article-OPTHhttps://doaj.org/toc/1177-5483David McMullin,1 David Clark,1 Bill Cavanagh,1 Paul Karpecki,2 Todd C Brady1 1Aldeyra Therapeutics, Inc, Lexington, MA, USA; 2Kentucky Eye Institute, Lexington, KY, USACorrespondence: Todd C BradyAldeyra Therapeutics, Inc, 131 Hartwell Avenue, Suite 320, Lexington, MA, 02421, USATel +1 781 761-4904Email tbrady@aldeyra.comPurpose: To assess the subjective eye drop experience of patients with dry eye disease (DED) over approximately 1 hour after a single dose of two formulations of reproxalap versus lifitegrast.Methods: Two formulations of topical ocular reproxalap 0.25% were evaluated versus lifitegrast ophthalmic solution 5% in patients with DED in a single-center, double-masked, active-comparator, single-dose crossover clinical trial. Nineteen patients had test article topically administered to both eyes. Treatments were administered 2 to 4 days apart. Comfort assessments, including ocular discomfort, blurry vision, and dysgeusia assessments; ocular descriptive assessments; quality of life assessments; and overall experience questions were completed after each treatment over one hour, beginning at 90 seconds.Results: Both reproxalap formulations scored better in ocular discomfort score (ODS), blurry vision, and dysgeusia assessments than lifitegrast at each timepoint and cumulatively over all time points after instillation. There were lower rates of negative responses for both reproxalap formulations compared to lifitegrast across ocular discomfort, blurry vision, and dysgeusia assessments, and the durations of negative responses were shorter with reproxalap than with lifitegrast. The reproxalap groups experienced fewer quality of life impacts. No significant safety findings were observed following reproxalap or lifitegrast administration.Conclusion: The reproxalap eye drop experience over 1 hour after instillation was superior to that of lifitegrast. There were no statistically significant differences between reproxalap groups for ODS, blurry vision, or dysgeusia. The improved performance of reproxalap with regard to the most commonly reported side effects of lifitegrast (ie, ocular discomfort, blurry vision, and dysgeusia) may result in greater patient adherence and lower discontinuation rates.Keywords: RASP inhibitor, dry eye disease, inflammation, reproxalap, lifitegrast, eye drop comfortMcMullin DClark DCavanagh BKarpecki PBrady TCDove Medical Pressarticlerasp inhibitordry eye diseaseinflammationreproxalaplifitegrasteye drop comfort OphthalmologyRE1-994ENClinical Ophthalmology, Vol Volume 15, Pp 3889-3900 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	rasp inhibitor dry eye disease inflammation reproxalap lifitegrast eye drop comfort Ophthalmology RE1-994
spellingShingle	rasp inhibitor dry eye disease inflammation reproxalap lifitegrast eye drop comfort Ophthalmology RE1-994 McMullin D Clark D Cavanagh B Karpecki P Brady TC A Post-Acute Ocular Tolerability Comparison of Topical Reproxalap 0.25% and Lifitegrast 5% in Patients with Dry Eye Disease
description	David McMullin,1 David Clark,1 Bill Cavanagh,1 Paul Karpecki,2 Todd C Brady1 1Aldeyra Therapeutics, Inc, Lexington, MA, USA; 2Kentucky Eye Institute, Lexington, KY, USACorrespondence: Todd C BradyAldeyra Therapeutics, Inc, 131 Hartwell Avenue, Suite 320, Lexington, MA, 02421, USATel +1 781 761-4904Email tbrady@aldeyra.comPurpose: To assess the subjective eye drop experience of patients with dry eye disease (DED) over approximately 1 hour after a single dose of two formulations of reproxalap versus lifitegrast.Methods: Two formulations of topical ocular reproxalap 0.25% were evaluated versus lifitegrast ophthalmic solution 5% in patients with DED in a single-center, double-masked, active-comparator, single-dose crossover clinical trial. Nineteen patients had test article topically administered to both eyes. Treatments were administered 2 to 4 days apart. Comfort assessments, including ocular discomfort, blurry vision, and dysgeusia assessments; ocular descriptive assessments; quality of life assessments; and overall experience questions were completed after each treatment over one hour, beginning at 90 seconds.Results: Both reproxalap formulations scored better in ocular discomfort score (ODS), blurry vision, and dysgeusia assessments than lifitegrast at each timepoint and cumulatively over all time points after instillation. There were lower rates of negative responses for both reproxalap formulations compared to lifitegrast across ocular discomfort, blurry vision, and dysgeusia assessments, and the durations of negative responses were shorter with reproxalap than with lifitegrast. The reproxalap groups experienced fewer quality of life impacts. No significant safety findings were observed following reproxalap or lifitegrast administration.Conclusion: The reproxalap eye drop experience over 1 hour after instillation was superior to that of lifitegrast. There were no statistically significant differences between reproxalap groups for ODS, blurry vision, or dysgeusia. The improved performance of reproxalap with regard to the most commonly reported side effects of lifitegrast (ie, ocular discomfort, blurry vision, and dysgeusia) may result in greater patient adherence and lower discontinuation rates.Keywords: RASP inhibitor, dry eye disease, inflammation, reproxalap, lifitegrast, eye drop comfort
format	article
author	McMullin D Clark D Cavanagh B Karpecki P Brady TC
author_facet	McMullin D Clark D Cavanagh B Karpecki P Brady TC
author_sort	McMullin D
title	A Post-Acute Ocular Tolerability Comparison of Topical Reproxalap 0.25% and Lifitegrast 5% in Patients with Dry Eye Disease
title_short	A Post-Acute Ocular Tolerability Comparison of Topical Reproxalap 0.25% and Lifitegrast 5% in Patients with Dry Eye Disease
title_full	A Post-Acute Ocular Tolerability Comparison of Topical Reproxalap 0.25% and Lifitegrast 5% in Patients with Dry Eye Disease
title_fullStr	A Post-Acute Ocular Tolerability Comparison of Topical Reproxalap 0.25% and Lifitegrast 5% in Patients with Dry Eye Disease
title_full_unstemmed	A Post-Acute Ocular Tolerability Comparison of Topical Reproxalap 0.25% and Lifitegrast 5% in Patients with Dry Eye Disease
title_sort	post-acute ocular tolerability comparison of topical reproxalap 0.25% and lifitegrast 5% in patients with dry eye disease
publisher	Dove Medical Press
publishDate	2021
url	https://doaj.org/article/8ed6c8cfce4d4c78970537ad6781fa01
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A Post-Acute Ocular Tolerability Comparison of Topical Reproxalap 0.25% and Lifitegrast 5% in Patients with Dry Eye Disease

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