Effect of benzalkonium chloride-free latanoprost ophthalmic solution on ocular surface in patients with glaucoma

Tejaswini Walimbe,1 Vidya Chelerkar,2 Purvi Bhagat,3 Abhijeet Joshi,4 Atul Raut4 1Walimbe Eye Clinic, 2PBMA’s H.V. Desai Eye Hospital, Pune, 3Glaucoma Clinic, M and J Western Regional Institute of Ophthalmology, Civil Hospital, Ahmedabad, 4Clinical Research Department, Sun Pharma Advanced...

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Autores principales:	Walimbe T, Chelerkar V, Bhagat P, Joshi A, Raut A
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2016
Materias:	tear breakup time (TBUT) Ocular Surface Disease Index (OSDI©) inferior corneal staining score conjunctival hyperemia intraocular pressure Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/8d5799b8d5864060a340f146b499aef2
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spelling	oai:doaj.org-article:8d5799b8d5864060a340f146b499aef22021-12-02T03:38:39ZEffect of benzalkonium chloride-free latanoprost ophthalmic solution on ocular surface in patients with glaucoma1177-5483https://doaj.org/article/8d5799b8d5864060a340f146b499aef22016-05-01T00:00:00Zhttps://www.dovepress.com/effect-of-benzalkonium-chloride-free-latanoprost-ophthalmic-solution-o-peer-reviewed-article-OPTHhttps://doaj.org/toc/1177-5483Tejaswini Walimbe,1 Vidya Chelerkar,2 Purvi Bhagat,3 Abhijeet Joshi,4 Atul Raut4 1Walimbe Eye Clinic, 2PBMA’s H.V. Desai Eye Hospital, Pune, 3Glaucoma Clinic, M and J Western Regional Institute of Ophthalmology, Civil Hospital, Ahmedabad, 4Clinical Research Department, Sun Pharma Advanced Research Company Ltd., Mumbai, India Introduction: Benzalkonium chloride (BAK), included as a preservative in many topical treatments for glaucoma, induces significant toxicity and alters tear breakup time (TBUT). BAK-containing latanoprost, an ester prodrug of prostaglandin F2a, can cause ocular adverse events (AEs) associated with BAK. The purpose of this study was to evaluate the efficacy and safety of BAK-free latanoprost. Patients and methods: A prospective, open-label, single-arm, multicenter, 8-week study in patients with primary open-angle glaucoma or ocular hypertension taking BAK-containing latanoprost for ≥12 months was performed. Patients were switched to BAK-free latanoprost ophthalmic solution 0.005% administered once daily, and eyes were assessed after 28 and 56 days. Primary efficacy and safety variables were TBUT and treatment-emergent AEs, respectively. Results: At day 56, 40 eyes were evaluable. Mean TBUT increased significantly from baseline (3.67±1.60 seconds) to 5.03±2.64 and 6.06±3.39 seconds after 28 and 56 days of treatment with BAK-free latanoprost (P<0.0001). Ocular Surface Disease Index© (OSDI©) score also decreased significantly to 12.06±13.40 and 7.06±10.75 at 28 and 56 days, respectively, versus baseline (18.09±18.61, P<0.0001). In addition, inferior corneal staining score decreased significantly to 0.53 from baseline (0.85, P=0.0033). A reduction in conjunctival hyperemia and intraocular pressure was observed at both time points. No treatment-related serious AEs were evident and 12 (26.08%) treatment-emergent AEs occurred in seven patients, with eye pain and irritation being the most frequent. No clinically significant changes in vital signs or slit lamp examinations were observed. Conclusion: Results indicate that switching from BAK-containing latanoprost to BAK-free latanoprost resulted in significant improvements in TBUT, OSDI© score, and inferior corneal staining score, and measurable reductions in conjunctival hyperemia score. Furthermore, BAK-free latanoprost was well tolerated with only mild-to-moderate and self-limiting AEs. BAK-free latanoprost appears to be effective in protecting ocular surface integrity in glaucoma patients but further studies are needed to confirm this beneficial effect. Keywords: tear breakup time, TBUT, Ocular Surface Disease Index, OSDI©, inferior corneal staining score, conjunctival hyperemia, intraocular pressure, glaucoma, ocular surfaceWalimbe TChelerkar VBhagat PJoshi ARaut ADove Medical Pressarticletear breakup time (TBUT)Ocular Surface Disease Index (OSDI©)inferior corneal staining scoreconjunctival hyperemiaintraocular pressureOphthalmologyRE1-994ENClinical Ophthalmology, Vol 2016, Iss Issue 1, Pp 821-827 (2016)
institution	DOAJ
collection	DOAJ
language	EN
topic	tear breakup time (TBUT) Ocular Surface Disease Index (OSDI©) inferior corneal staining score conjunctival hyperemia intraocular pressure Ophthalmology RE1-994
spellingShingle	tear breakup time (TBUT) Ocular Surface Disease Index (OSDI©) inferior corneal staining score conjunctival hyperemia intraocular pressure Ophthalmology RE1-994 Walimbe T Chelerkar V Bhagat P Joshi A Raut A Effect of benzalkonium chloride-free latanoprost ophthalmic solution on ocular surface in patients with glaucoma
description	Tejaswini Walimbe,1 Vidya Chelerkar,2 Purvi Bhagat,3 Abhijeet Joshi,4 Atul Raut4 1Walimbe Eye Clinic, 2PBMA’s H.V. Desai Eye Hospital, Pune, 3Glaucoma Clinic, M and J Western Regional Institute of Ophthalmology, Civil Hospital, Ahmedabad, 4Clinical Research Department, Sun Pharma Advanced Research Company Ltd., Mumbai, India Introduction: Benzalkonium chloride (BAK), included as a preservative in many topical treatments for glaucoma, induces significant toxicity and alters tear breakup time (TBUT). BAK-containing latanoprost, an ester prodrug of prostaglandin F2a, can cause ocular adverse events (AEs) associated with BAK. The purpose of this study was to evaluate the efficacy and safety of BAK-free latanoprost. Patients and methods: A prospective, open-label, single-arm, multicenter, 8-week study in patients with primary open-angle glaucoma or ocular hypertension taking BAK-containing latanoprost for ≥12 months was performed. Patients were switched to BAK-free latanoprost ophthalmic solution 0.005% administered once daily, and eyes were assessed after 28 and 56 days. Primary efficacy and safety variables were TBUT and treatment-emergent AEs, respectively. Results: At day 56, 40 eyes were evaluable. Mean TBUT increased significantly from baseline (3.67±1.60 seconds) to 5.03±2.64 and 6.06±3.39 seconds after 28 and 56 days of treatment with BAK-free latanoprost (P<0.0001). Ocular Surface Disease Index© (OSDI©) score also decreased significantly to 12.06±13.40 and 7.06±10.75 at 28 and 56 days, respectively, versus baseline (18.09±18.61, P<0.0001). In addition, inferior corneal staining score decreased significantly to 0.53 from baseline (0.85, P=0.0033). A reduction in conjunctival hyperemia and intraocular pressure was observed at both time points. No treatment-related serious AEs were evident and 12 (26.08%) treatment-emergent AEs occurred in seven patients, with eye pain and irritation being the most frequent. No clinically significant changes in vital signs or slit lamp examinations were observed. Conclusion: Results indicate that switching from BAK-containing latanoprost to BAK-free latanoprost resulted in significant improvements in TBUT, OSDI© score, and inferior corneal staining score, and measurable reductions in conjunctival hyperemia score. Furthermore, BAK-free latanoprost was well tolerated with only mild-to-moderate and self-limiting AEs. BAK-free latanoprost appears to be effective in protecting ocular surface integrity in glaucoma patients but further studies are needed to confirm this beneficial effect. Keywords: tear breakup time, TBUT, Ocular Surface Disease Index, OSDI©, inferior corneal staining score, conjunctival hyperemia, intraocular pressure, glaucoma, ocular surface
format	article
author	Walimbe T Chelerkar V Bhagat P Joshi A Raut A
author_facet	Walimbe T Chelerkar V Bhagat P Joshi A Raut A
author_sort	Walimbe T
title	Effect of benzalkonium chloride-free latanoprost ophthalmic solution on ocular surface in patients with glaucoma
title_short	Effect of benzalkonium chloride-free latanoprost ophthalmic solution on ocular surface in patients with glaucoma
title_full	Effect of benzalkonium chloride-free latanoprost ophthalmic solution on ocular surface in patients with glaucoma
title_fullStr	Effect of benzalkonium chloride-free latanoprost ophthalmic solution on ocular surface in patients with glaucoma
title_full_unstemmed	Effect of benzalkonium chloride-free latanoprost ophthalmic solution on ocular surface in patients with glaucoma
title_sort	effect of benzalkonium chloride-free latanoprost ophthalmic solution on ocular surface in patients with glaucoma
publisher	Dove Medical Press
publishDate	2016
url	https://doaj.org/article/8d5799b8d5864060a340f146b499aef2
work_keys_str_mv	AT walimbet effectofbenzalkoniumchloridefreelatanoprostophthalmicsolutiononocularsurfaceinpatientswithglaucoma AT chelerkarv effectofbenzalkoniumchloridefreelatanoprostophthalmicsolutiononocularsurfaceinpatientswithglaucoma AT bhagatp effectofbenzalkoniumchloridefreelatanoprostophthalmicsolutiononocularsurfaceinpatientswithglaucoma AT joshia effectofbenzalkoniumchloridefreelatanoprostophthalmicsolutiononocularsurfaceinpatientswithglaucoma AT rauta effectofbenzalkoniumchloridefreelatanoprostophthalmicsolutiononocularsurfaceinpatientswithglaucoma
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Effect of benzalkonium chloride-free latanoprost ophthalmic solution on ocular surface in patients with glaucoma

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