Effect of benzalkonium chloride-preserved latanoprost and benzalkonium chloride-free latanoprost on intraocular pressure in patients of primary open angle glaucoma
DOI:
https://doi.org/10.18203/2320-6012.ijrms20182842Keywords:
Benzalkonium chloride-preserved latanoprost, Benzalkonium chloride-free latanoprost, Glaucoma, Latanoprost, Ocular surface diseaseAbstract
Background: To evaluate the change in mean IOP with BKC-preserved latanoprost versus BKC-free latanoprost in patients of primary open angle glaucoma (POAG).
Methods: This was an open-label, randomized, interventional, switch trial. Thirty patients of primary open angle glaucoma (POAG) who were already on benzalkonium chloride (BKC)-preserved latanoprost for a minimum of three months were recruited. Their intraocular pressure (IOP) was recorded at the baseline. Then, they were switched over to benzalkonium chloride (BKC)-free latanoprost for another three months. Their intraocular pressure (IOP) was recorded at both 6 and 12 weeks of follow-up.
Results: IOP decreased from 15.57±0.85mm Hg at baseline to 15.40±0.89mm Hg at 6 weeks to 15.30±0.70mm Hg at 12 weeks. p value was found to be 0.209 and 0.115 at 6 and 12 weeks respectively. No statistically significant change was observed between mean IOP at both 6 and 12 weeks as compared to the baseline.
Conclusions: BKC-free medications have equal IOP lowering effect as BKC-preserved medications in glaucoma patients.
References
Grierson I. The patient with primary open-angle glaucoma. Practitioner. 2000;244:654-8.
Marquis JE, Whitson JT. Management of glaucoma: focus on pharmacological therapy. Drugs and Aging. 2005;22(1):1-21.
Guidance for industry-container and closure system integrity testing in lieu of sterility testing as a component of the stability protocol for sterile products. Rockville, MD, USA: Food and Drug Administration. 2008 Feb. Available from: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM146076.pdf. Cited 2016 Sep 24.
He XG. Challenge and treatment strategy for ocular surface damage in patients with long term use of antiglaucoma drugs. Zhonghua Yan Ke Za Zhi. 2011 Feb;47(2):101-4.
Jaenen N, Baudouin C, Poliquen P. Ocular symptoms and signs with preserved and preservative-free glaucoma medications. Eur J Ophthalmol. 2007;17:341-9.
Tomić M, Kaštelan S, Soldo KM, Rabatić JS. How Ocular Surface Disease Impacts the Glaucoma Treatment Outcome. Biomed Res Int. 2013;2013:1-7.
Yee RW, Norcom EG, Zhao XC. Comparison of the relative toxicity of travoprost 0.004% without benzalkonium chloride and latanoprost 0.005% in an immortalized human cornea epithelial cell culture system. Adv Ther. 2006;23:511-9.
Chung SH, Lee SK, Cristol SM. Impact of short-term exposure of commercial eyedrops preserved with benzalkonium chloride on precorneal mucin. Mol Vis. 2006;12:415-2.
Clouzeau C, Godefroy D, Riancho L, Rostène W, Baudouin C, Brignole-Baudouin F. Hyperosmolarity potentiates toxic effects of benzalkonium chloride on conjunctival epithelial cells in vitro. Molecular Vision. 2012;18:851-63.
Chang C, Zhang AQ, Kagan DB, Liu H, Hutnik CM. Mechanisms of benzalkonium chloride toxicity in a human trabecular meshwork cell line and the protective role of preservative-free tafluprost. Clin Experimental Ophthalmology. 2015;43:164-72.
Gassett AR, Ishii Y, Kaufman HE, Miller T. Cytotoxicity of ophthalmic preservatives. AM J Opthalmol. 1974;78:98-105.
12. Yalvaç IS, Gedikoğlu G, Karagöz Y, Akgün U, Nurözler A, Koç F. Effects of antiglaucoma drugs on ocular surface. Acta Ophthalmol Scand. 1995 Jun;73(3):246-8.
Martone G, Frezzotti P, Tosi GM. An in vivo confocal microscopy analysis of effects of topical antiglaucoma therapy with preservative on corneal innervation and morphology. Am J Ophthalmol. 2009;147(4):725-35.
Uusitalo H, Chen E, Pfeiffer N. Switching from a preserved to a preservative-free prostaglandin preparation in topical glaucoma medication. Acta ophthalmol. 2010;88(3):329-36.
Shehata AM. Preserved prostaglandin analog and ocular surface disorders in open-angle glaucoma. Med J Cairo Univ. 2015;83(1):109-14.
Wang YQ, Wang X, Liu P. Meta analysis about the efficacy and safety of anti-ocular hypertension eye drops without benzalkonium chloride. Asian Pacific Journal of Tropical Medicine. 2013:1004-8.
Goldberg I, Graham SL, Crowston JG, d’Mellow G. Clinical audit examining the impact of benzalkonium chloride-free anti-glaucoma medications on patients with symptoms of ocular surface disease. Clin Exp Ophthalmol. 2015;43(3):214-20.
Miyashiro MJ, Lo SC, Stewart JA, Stewart WC. Efficacy, safety and tolerability of travoprost 0.004 % BAK-free versus prior treatment with latanoprost 0.005% in Japanese patients. Clin Ophthalmol. 2010;4:1355-9.
Hamacher T, Airaksinen J, Saarela V, Liinamaa MJ, Richter U, Ropo A. Efficacy and safety levels of preserved and preservative-free tafluprost are equivalent in patients with glaucoma or ocular hypertension: results from a pharmacodynamic analysis. Acta Ophthalmologica. 2008;86(s242):14-19.
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. Clin Ophthalmol. 2016;10:821-7.
Hommer A, Kimmich F. Switching patients from preserved prostaglandin-analog monotherapy to preservative free tafluprost. Clinical Ophthalmol. 2011;5:623-31.