Clinical Evaluation of a Novel Electromechanical Topical Ocular Drug Delivery System: Two Phase 1 Proof of Concept Studies

Hugo Quiroz-Mercado, 1 Ehud Ivri, 2 Roberto Gonzalez-Salinas, 1 Iraklis C Kourtis, 2 Joseph Gilbert, 2 José Francisco Pérez-Vázquez, 1 Mark Blumenkranz, 2 Jesús Jiménez-Román, 1 George Marcellino 2 1Association to Prevent Blindness,...

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Autores principales:	Quiroz-Mercado H, Ivri E, Gonzalez-Salinas R, Kourtis IC, Gilbert J, Pérez-Vázquez JF, Blumenkranz M, Jiménez-Román J, Marcellino G
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2020
Materias:	mydriasis phenylephrine tropicamide glaucoma intraocular pressure latanoprost topical ocular drug delivery safety Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/ece07883a85a439abce65e97e1a190da
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spelling	oai:doaj.org-article:ece07883a85a439abce65e97e1a190da2021-12-02T09:52:14ZClinical Evaluation of a Novel Electromechanical Topical Ocular Drug Delivery System: Two Phase 1 Proof of Concept Studies1177-5483https://doaj.org/article/ece07883a85a439abce65e97e1a190da2020-01-01T00:00:00Zhttps://www.dovepress.com/clinical-evaluation-of-a-novel-electromechanical-topical-ocular-drug-d-peer-reviewed-article-OPTHhttps://doaj.org/toc/1177-5483Hugo Quiroz-Mercado, 1 Ehud Ivri, 2 Roberto Gonzalez-Salinas, 1 Iraklis C Kourtis, 2 Joseph Gilbert, 2 José Francisco Pérez-Vázquez, 1 Mark Blumenkranz, 2 Jesús Jiménez-Román, 1 George Marcellino 2 1Association to Prevent Blindness, Hospital Sanchez-Bulnes, Mexico City, Mexico; 2Kedalion Therapeutics Inc., Menlo Park, CA, USACorrespondence: Hugo Quiroz-Mercado Vicente García Torres #46, Coyoacan, CDMX CP 04330, MexicoTel/Fax +52-5-10841-400Email hugoquiroz@yahoo.comPurpose: Self-administration of topical ophthalmic therapies remains challenging for many patients as errors due to improper technique are common. The aim of the current studies was to evaluate a novel electromechanical topical ocular drug delivery device designed to facilitate precise dosing and accurate delivery with substantially lower drug exposure than conventional eye drops.Patients and Methods: Two randomized Phase 1 studies were performed to evaluate the efficacy and safety of a single dose of a topical ophthalmic solution administered as a &sim; 9 μL microfluid stream via the test device compared with a &sim; 30– 40 μL drop delivered via conventional dropper in healthy subjects (Trial 1) and glaucoma patients (Trial 2). In Trial 1, a 1% tropicamide/2.5% phenylephrine solution was administered via the test device in one eye and by conventional dropper in the contralateral eye. Pupil dilation was measured at 30 min intervals post-instillation and subject comfort was assessed using a visual analogue scale (range, 0– 100). In Trial 2, patients were randomized to receive latanoprost 0.005% via the test device or conventional dropper. Intraocular pressure was measured at baseline and 4– 8 hrs post-instillation.Results: In Trial 1 (N=20), mean (SD) pupil diameter 30 mins post-instillation increased by 3.4 (0.9) and 3.5 (1.0) mm in the test and control eyes, respectively. The mean comfort score was 81.7 for the test device versus 57.3 for conventional dropper delivery. In Trial 2 (N=18), the mean change in intraocular pressure following administration of latanoprost was – 5.0 (1.8) and – 4.3 (3.3) mm Hg in the test and control groups, respectively. No serious adverse events were observed in either study.Conclusion: Administration of a single dose of topical ophthalmic therapy via an electromechanical drug delivery device resulted in comparable effects on pupil dilation and intraocular pressure with lower drug exposure and increased patient comfort compared with conventional dropper delivery.Keywords: mydriasis, phenylephrine, tropicamide, glaucoma, intraocular pressure, latanoprost, topical ocular drug delivery, safetyQuiroz-Mercado HIvri EGonzalez-Salinas RKourtis ICGilbert JPérez-Vázquez JFBlumenkranz MJiménez-Román JMarcellino GDove Medical Pressarticlemydriasisphenylephrinetropicamideglaucomaintraocular pressurelatanoprosttopical ocular drug deliverysafetyOphthalmologyRE1-994ENClinical Ophthalmology, Vol Volume 14, Pp 139-147 (2020)
institution	DOAJ
collection	DOAJ
language	EN
topic	mydriasis phenylephrine tropicamide glaucoma intraocular pressure latanoprost topical ocular drug delivery safety Ophthalmology RE1-994
spellingShingle	mydriasis phenylephrine tropicamide glaucoma intraocular pressure latanoprost topical ocular drug delivery safety Ophthalmology RE1-994 Quiroz-Mercado H Ivri E Gonzalez-Salinas R Kourtis IC Gilbert J Pérez-Vázquez JF Blumenkranz M Jiménez-Román J Marcellino G Clinical Evaluation of a Novel Electromechanical Topical Ocular Drug Delivery System: Two Phase 1 Proof of Concept Studies
description	Hugo Quiroz-Mercado, 1 Ehud Ivri, 2 Roberto Gonzalez-Salinas, 1 Iraklis C Kourtis, 2 Joseph Gilbert, 2 José Francisco Pérez-Vázquez, 1 Mark Blumenkranz, 2 Jesús Jiménez-Román, 1 George Marcellino 2 1Association to Prevent Blindness, Hospital Sanchez-Bulnes, Mexico City, Mexico; 2Kedalion Therapeutics Inc., Menlo Park, CA, USACorrespondence: Hugo Quiroz-Mercado Vicente García Torres #46, Coyoacan, CDMX CP 04330, MexicoTel/Fax +52-5-10841-400Email hugoquiroz@yahoo.comPurpose: Self-administration of topical ophthalmic therapies remains challenging for many patients as errors due to improper technique are common. The aim of the current studies was to evaluate a novel electromechanical topical ocular drug delivery device designed to facilitate precise dosing and accurate delivery with substantially lower drug exposure than conventional eye drops.Patients and Methods: Two randomized Phase 1 studies were performed to evaluate the efficacy and safety of a single dose of a topical ophthalmic solution administered as a &sim; 9 μL microfluid stream via the test device compared with a &sim; 30– 40 μL drop delivered via conventional dropper in healthy subjects (Trial 1) and glaucoma patients (Trial 2). In Trial 1, a 1% tropicamide/2.5% phenylephrine solution was administered via the test device in one eye and by conventional dropper in the contralateral eye. Pupil dilation was measured at 30 min intervals post-instillation and subject comfort was assessed using a visual analogue scale (range, 0– 100). In Trial 2, patients were randomized to receive latanoprost 0.005% via the test device or conventional dropper. Intraocular pressure was measured at baseline and 4– 8 hrs post-instillation.Results: In Trial 1 (N=20), mean (SD) pupil diameter 30 mins post-instillation increased by 3.4 (0.9) and 3.5 (1.0) mm in the test and control eyes, respectively. The mean comfort score was 81.7 for the test device versus 57.3 for conventional dropper delivery. In Trial 2 (N=18), the mean change in intraocular pressure following administration of latanoprost was – 5.0 (1.8) and – 4.3 (3.3) mm Hg in the test and control groups, respectively. No serious adverse events were observed in either study.Conclusion: Administration of a single dose of topical ophthalmic therapy via an electromechanical drug delivery device resulted in comparable effects on pupil dilation and intraocular pressure with lower drug exposure and increased patient comfort compared with conventional dropper delivery.Keywords: mydriasis, phenylephrine, tropicamide, glaucoma, intraocular pressure, latanoprost, topical ocular drug delivery, safety
format	article
author	Quiroz-Mercado H Ivri E Gonzalez-Salinas R Kourtis IC Gilbert J Pérez-Vázquez JF Blumenkranz M Jiménez-Román J Marcellino G
author_facet	Quiroz-Mercado H Ivri E Gonzalez-Salinas R Kourtis IC Gilbert J Pérez-Vázquez JF Blumenkranz M Jiménez-Román J Marcellino G
author_sort	Quiroz-Mercado H
title	Clinical Evaluation of a Novel Electromechanical Topical Ocular Drug Delivery System: Two Phase 1 Proof of Concept Studies
title_short	Clinical Evaluation of a Novel Electromechanical Topical Ocular Drug Delivery System: Two Phase 1 Proof of Concept Studies
title_full	Clinical Evaluation of a Novel Electromechanical Topical Ocular Drug Delivery System: Two Phase 1 Proof of Concept Studies
title_fullStr	Clinical Evaluation of a Novel Electromechanical Topical Ocular Drug Delivery System: Two Phase 1 Proof of Concept Studies
title_full_unstemmed	Clinical Evaluation of a Novel Electromechanical Topical Ocular Drug Delivery System: Two Phase 1 Proof of Concept Studies
title_sort	clinical evaluation of a novel electromechanical topical ocular drug delivery system: two phase 1 proof of concept studies
publisher	Dove Medical Press
publishDate	2020
url	https://doaj.org/article/ece07883a85a439abce65e97e1a190da
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Clinical Evaluation of a Novel Electromechanical Topical Ocular Drug Delivery System: Two Phase 1 Proof of Concept Studies

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