A Phase II/III, randomized, double-masked, vehicle-controlled, dose-ranging study of the safety and efficacy of OTX-101 in the treatment of dry eye disease

Joseph Tauber,1 Barry A Schechter,2 Jason Bacharach,3 Melissa M Toyos,4 Robert Smyth-Medina,5 Sidney L Weiss,6 Jodi I Luchs7 1Tauber Eye Center, Kansas City, MO, USA; 2Florida Eye Microsurgical Institute, Boynton Beach, FL, USA; 3North Bay Eye Associates, Petaluma, CA, USA; 4Toyos Clinic, Nashville...

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Autores principales:	Tauber J, Schechter BA, Bacharach J, Toyos MM, Smyth-Medina R, Weiss SL, Luchs JI
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2018
Materias:	Dry eye disease cyclosporine inflammation Schirmer test Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/d3081699ac5545039b3bca544fc4d571
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spelling	oai:doaj.org-article:d3081699ac5545039b3bca544fc4d5712021-12-02T09:34:15ZA Phase II/III, randomized, double-masked, vehicle-controlled, dose-ranging study of the safety and efficacy of OTX-101 in the treatment of dry eye disease1177-5483https://doaj.org/article/d3081699ac5545039b3bca544fc4d5712018-10-01T00:00:00Zhttps://www.dovepress.com/a-phase-iiiii-randomized-double-masked-vehicle-controlled-dose-ranging-peer-reviewed-article-OPTHhttps://doaj.org/toc/1177-5483Joseph Tauber,1 Barry A Schechter,2 Jason Bacharach,3 Melissa M Toyos,4 Robert Smyth-Medina,5 Sidney L Weiss,6 Jodi I Luchs7 1Tauber Eye Center, Kansas City, MO, USA; 2Florida Eye Microsurgical Institute, Boynton Beach, FL, USA; 3North Bay Eye Associates, Petaluma, CA, USA; 4Toyos Clinic, Nashville, TN, USA; 5North Valley Eye Medical Group, Mission Hills, CA, USA; 6i-Novion, Inc, Randolph, NJ, USA; 7South Shore Eye Care, Wantagh, NY, USA Purpose: The aim of this study was to evaluate the safety and efficacy of OTX-101, a clear nanomicellar aqueous solution of cyclosporine, in the treatment of dry eye disease (DED).Patients and methods: This was a 12-week multicenter, randomized, prospective, double-masked, vehicle-controlled, dose-ranging clinical trial. Subjects were adults aged ≥18 years, with a total conjunctival staining score of ≥3 and ≤9, and global DED symptom score ≥40 (0–100 visual analogue scale). Following a 14-day vehicle run-in, subjects were randomized in a 1:1:1 ratio to twice daily treatment with OTX-101 0.09%, OTX-101 0.05%, or vehicle for 84 days. Co-primary efficacy end points were changes, from baseline to Day 84, in the total lissamine green conjunctival staining score in the designated study eye and in the global symptom score (both eyes). Secondary end points included total corneal fluorescein staining score, tear breakup time, and Schirmer’s test score.Results: In total, 455 subjects were randomized. Subjects treated with active drug experienced greater improvement in conjunctival staining than vehicle-treated patients (P<0.01 for both concentrations). All groups demonstrated improvements in global symptom score, but there were no differences among groups. Nominally significant differences were found between the active drug arms and vehicle for corneal staining scores and Schirmer’s test scores. Most treatment-emergent adverse events were mild in severity; no serious ocular adverse events were reported.Conclusions: Both concentrations of OTX-101 met the co-primary sign end point (conjunctival staining) but not the co-primary symptom end point. OTX-101 0.09% demonstrated a notable impact on multiple signs of DED relative to vehicle and was well-tolerated. Keywords: dry eye disease, cyclosporine, inflammation, Schirmer’s testTauber JSchechter BABacharach JToyos MMSmyth-Medina RWeiss SLLuchs JIDove Medical PressarticleDry eye diseasecyclosporineinflammationSchirmer testOphthalmologyRE1-994ENClinical Ophthalmology, Vol Volume 12, Pp 1921-1929 (2018)
institution	DOAJ
collection	DOAJ
language	EN
topic	Dry eye disease cyclosporine inflammation Schirmer test Ophthalmology RE1-994
spellingShingle	Dry eye disease cyclosporine inflammation Schirmer test Ophthalmology RE1-994 Tauber J Schechter BA Bacharach J Toyos MM Smyth-Medina R Weiss SL Luchs JI A Phase II/III, randomized, double-masked, vehicle-controlled, dose-ranging study of the safety and efficacy of OTX-101 in the treatment of dry eye disease
description	Joseph Tauber,1 Barry A Schechter,2 Jason Bacharach,3 Melissa M Toyos,4 Robert Smyth-Medina,5 Sidney L Weiss,6 Jodi I Luchs7 1Tauber Eye Center, Kansas City, MO, USA; 2Florida Eye Microsurgical Institute, Boynton Beach, FL, USA; 3North Bay Eye Associates, Petaluma, CA, USA; 4Toyos Clinic, Nashville, TN, USA; 5North Valley Eye Medical Group, Mission Hills, CA, USA; 6i-Novion, Inc, Randolph, NJ, USA; 7South Shore Eye Care, Wantagh, NY, USA Purpose: The aim of this study was to evaluate the safety and efficacy of OTX-101, a clear nanomicellar aqueous solution of cyclosporine, in the treatment of dry eye disease (DED).Patients and methods: This was a 12-week multicenter, randomized, prospective, double-masked, vehicle-controlled, dose-ranging clinical trial. Subjects were adults aged ≥18 years, with a total conjunctival staining score of ≥3 and ≤9, and global DED symptom score ≥40 (0–100 visual analogue scale). Following a 14-day vehicle run-in, subjects were randomized in a 1:1:1 ratio to twice daily treatment with OTX-101 0.09%, OTX-101 0.05%, or vehicle for 84 days. Co-primary efficacy end points were changes, from baseline to Day 84, in the total lissamine green conjunctival staining score in the designated study eye and in the global symptom score (both eyes). Secondary end points included total corneal fluorescein staining score, tear breakup time, and Schirmer’s test score.Results: In total, 455 subjects were randomized. Subjects treated with active drug experienced greater improvement in conjunctival staining than vehicle-treated patients (P<0.01 for both concentrations). All groups demonstrated improvements in global symptom score, but there were no differences among groups. Nominally significant differences were found between the active drug arms and vehicle for corneal staining scores and Schirmer’s test scores. Most treatment-emergent adverse events were mild in severity; no serious ocular adverse events were reported.Conclusions: Both concentrations of OTX-101 met the co-primary sign end point (conjunctival staining) but not the co-primary symptom end point. OTX-101 0.09% demonstrated a notable impact on multiple signs of DED relative to vehicle and was well-tolerated. Keywords: dry eye disease, cyclosporine, inflammation, Schirmer’s test
format	article
author	Tauber J Schechter BA Bacharach J Toyos MM Smyth-Medina R Weiss SL Luchs JI
author_facet	Tauber J Schechter BA Bacharach J Toyos MM Smyth-Medina R Weiss SL Luchs JI
author_sort	Tauber J
title	A Phase II/III, randomized, double-masked, vehicle-controlled, dose-ranging study of the safety and efficacy of OTX-101 in the treatment of dry eye disease
title_short	A Phase II/III, randomized, double-masked, vehicle-controlled, dose-ranging study of the safety and efficacy of OTX-101 in the treatment of dry eye disease
title_full	A Phase II/III, randomized, double-masked, vehicle-controlled, dose-ranging study of the safety and efficacy of OTX-101 in the treatment of dry eye disease
title_fullStr	A Phase II/III, randomized, double-masked, vehicle-controlled, dose-ranging study of the safety and efficacy of OTX-101 in the treatment of dry eye disease
title_full_unstemmed	A Phase II/III, randomized, double-masked, vehicle-controlled, dose-ranging study of the safety and efficacy of OTX-101 in the treatment of dry eye disease
title_sort	phase ii/iii, randomized, double-masked, vehicle-controlled, dose-ranging study of the safety and efficacy of otx-101 in the treatment of dry eye disease
publisher	Dove Medical Press
publishDate	2018
url	https://doaj.org/article/d3081699ac5545039b3bca544fc4d571
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A Phase II/III, randomized, double-masked, vehicle-controlled, dose-ranging study of the safety and efficacy of OTX-101 in the treatment of dry eye disease

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