Ocular iontophoresis of EGP-437 (dexamethasone phosphate) in dry eye patients: results of a randomized clinical trial

Michael A Patane&sup1;, Amy Cohen&sup1;, Stephen From&sup1;, Gail Torkildsen&sup2;, Donna Welch&sup3;, George W Ousler III&sup3;&sup1;Eyegate Pharmaceuticals, Inc, Waltham, MA, USA; &sup2;Andover Eye Associates, Andover, MA, USA; &a...

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Autores principales:	Patane MA, Cohen A, From S, Torkildsen G, Welch D, Ousler GW 3rd
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2011
Materias:	Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/f7ea8f1efe324a0e9cafdfd284ab518d
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spelling	oai:doaj.org-article:f7ea8f1efe324a0e9cafdfd284ab518d2021-12-02T05:25:27ZOcular iontophoresis of EGP-437 (dexamethasone phosphate) in dry eye patients: results of a randomized clinical trial1177-54671177-5483https://doaj.org/article/f7ea8f1efe324a0e9cafdfd284ab518d2011-05-01T00:00:00Zhttp://www.dovepress.com/ocular-iontophoresis-of-egp-437-dexamethasone-phosphate-in-dry-eye-pat-a7466https://doaj.org/toc/1177-5467https://doaj.org/toc/1177-5483Michael A Patane&sup1;, Amy Cohen&sup1;, Stephen From&sup1;, Gail Torkildsen&sup2;, Donna Welch&sup3;, George W Ousler III&sup3;&sup1;Eyegate Pharmaceuticals, Inc, Waltham, MA, USA; &sup2;Andover Eye Associates, Andover, MA, USA; &sup3;Ora, Inc, Andover, MA, USAPurpose: To assess safety and efficacy of EGP-437 (dexamethasone phosphate 40 mg/mL [DP]) in dry eye patients.Methods: The study employed a prospective, single-center, double-masked design utilizing a Controlled Adverse Environment (CAE). Patients (n = 103) with confirmed signs and symptoms of dry eye syndrome were randomized into 1 of 3 iontophoresis treatment groups: 7.5 mA-min at 2.5 mA (DP 7.5, n = 41); 10.5 mA-min at 3.5 mA (DP 10.5, n = 37); or 10.5 mA-min at 3.5 mA (placebo, n = 25). Three CAE visits and 4 follow-up visits occurred over 3 weeks. Patients meeting enrollment criteria received iontophoresis in both eyes after the second CAE exposure (visit 3) and before the third CAE exposure (visit 5). Primary efficacy endpoints were corneal staining and ocular discomfort. Secondary endpoints included tear film break-up time, ocular protection index (OPI), and symptomatology.Results: The DP 7.5 and DP 10.5 treatment groups showed statistically significant improvements in signs and symptoms of dry eye at various time points; however, the primary endpoints were not achieved. The DP 7.5 treatment group exhibited statistically significant improvements in corneal staining (when comparing the differences between study entry and exit, 3 weeks, P = 0.039), OPI (immediately following the second treatment, P = 0.048) and ocular discomfort at follow-up visits (a week after the first treatment, P = 0.032; 24 hours after the second treatment, P = 0.0032). Treatment-emergent adverse events (AEs) were experienced by 87% of patients and were consistent across all treatment groups. Most AEs were mild and no severe AEs were observed.Conclusion: Ocular iontophoresis of EGP-437 demonstrated statistically and clinically significant improvements in signs and symptoms of dry eye syndrome within a CAE model.Keywords: iontophoresis, dry eye, Controlled Adverse Environment (CAE), ocular protection index (OPI)Patane MACohen AFrom STorkildsen GWelch DOusler GW 3rdDove Medical PressarticleOphthalmologyRE1-994ENClinical Ophthalmology, Vol 2011, Iss default, Pp 633-643 (2011)
institution	DOAJ
collection	DOAJ
language	EN
topic	Ophthalmology RE1-994
spellingShingle	Ophthalmology RE1-994 Patane MA Cohen A From S Torkildsen G Welch D Ousler GW 3rd Ocular iontophoresis of EGP-437 (dexamethasone phosphate) in dry eye patients: results of a randomized clinical trial
description	Michael A Patane&sup1;, Amy Cohen&sup1;, Stephen From&sup1;, Gail Torkildsen&sup2;, Donna Welch&sup3;, George W Ousler III&sup3;&sup1;Eyegate Pharmaceuticals, Inc, Waltham, MA, USA; &sup2;Andover Eye Associates, Andover, MA, USA; &sup3;Ora, Inc, Andover, MA, USAPurpose: To assess safety and efficacy of EGP-437 (dexamethasone phosphate 40 mg/mL [DP]) in dry eye patients.Methods: The study employed a prospective, single-center, double-masked design utilizing a Controlled Adverse Environment (CAE). Patients (n = 103) with confirmed signs and symptoms of dry eye syndrome were randomized into 1 of 3 iontophoresis treatment groups: 7.5 mA-min at 2.5 mA (DP 7.5, n = 41); 10.5 mA-min at 3.5 mA (DP 10.5, n = 37); or 10.5 mA-min at 3.5 mA (placebo, n = 25). Three CAE visits and 4 follow-up visits occurred over 3 weeks. Patients meeting enrollment criteria received iontophoresis in both eyes after the second CAE exposure (visit 3) and before the third CAE exposure (visit 5). Primary efficacy endpoints were corneal staining and ocular discomfort. Secondary endpoints included tear film break-up time, ocular protection index (OPI), and symptomatology.Results: The DP 7.5 and DP 10.5 treatment groups showed statistically significant improvements in signs and symptoms of dry eye at various time points; however, the primary endpoints were not achieved. The DP 7.5 treatment group exhibited statistically significant improvements in corneal staining (when comparing the differences between study entry and exit, 3 weeks, P = 0.039), OPI (immediately following the second treatment, P = 0.048) and ocular discomfort at follow-up visits (a week after the first treatment, P = 0.032; 24 hours after the second treatment, P = 0.0032). Treatment-emergent adverse events (AEs) were experienced by 87% of patients and were consistent across all treatment groups. Most AEs were mild and no severe AEs were observed.Conclusion: Ocular iontophoresis of EGP-437 demonstrated statistically and clinically significant improvements in signs and symptoms of dry eye syndrome within a CAE model.Keywords: iontophoresis, dry eye, Controlled Adverse Environment (CAE), ocular protection index (OPI)
format	article
author	Patane MA Cohen A From S Torkildsen G Welch D Ousler GW 3rd
author_facet	Patane MA Cohen A From S Torkildsen G Welch D Ousler GW 3rd
author_sort	Patane MA
title	Ocular iontophoresis of EGP-437 (dexamethasone phosphate) in dry eye patients: results of a randomized clinical trial
title_short	Ocular iontophoresis of EGP-437 (dexamethasone phosphate) in dry eye patients: results of a randomized clinical trial
title_full	Ocular iontophoresis of EGP-437 (dexamethasone phosphate) in dry eye patients: results of a randomized clinical trial
title_fullStr	Ocular iontophoresis of EGP-437 (dexamethasone phosphate) in dry eye patients: results of a randomized clinical trial
title_full_unstemmed	Ocular iontophoresis of EGP-437 (dexamethasone phosphate) in dry eye patients: results of a randomized clinical trial
title_sort	ocular iontophoresis of egp-437 (dexamethasone phosphate) in dry eye patients: results of a randomized clinical trial
publisher	Dove Medical Press
publishDate	2011
url	https://doaj.org/article/f7ea8f1efe324a0e9cafdfd284ab518d
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Ocular iontophoresis of EGP-437 (dexamethasone phosphate) in dry eye patients: results of a randomized clinical trial

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