Safety and tolerability of the tafluprost/timolol fixed combination for the treatment of glaucoma

Bibliography

• European Glaucoma Society. Terminology and guidelines for glaucoma. 4th Edition. PubliComm Srl; Savona: 2014
   Google Scholar
• Holló G, Topouzis F, Fechtner RD. Fixed-combination intraocular pressure-lowering therapy for glaucoma and ocular hypertension: advantages in clinical practice. Expert Opin Pharmacother 2014;15:1737-47
   PubMed Web of Science ®Google Scholar
• Papadia M, Bagnis A, Scotto R, Traverso CE. Tafluprost for glaucoma. Expert Opin Pharmacother 2011;12:2393-401
   PubMedGoogle Scholar
• Pantcheva MB, Seibold LK, Awadallah NS, Kahook MY. Tafluprost: a novel prostaglandin analog for treatment of glaucoma. Adv Ther 2011;28:707-15
   PubMed Web of Science ®Google Scholar
• Traverso CE, Ropo A, Papadia M, Uusitalo H. A phase II study on the duration and stability of the intraocular pressure-lowering effect and tolerability of Tafluprost compared with latanoprost. J Ocul Pharmacol Ther 2010;26:97-104
   PubMed Web of Science ®Google Scholar
• Kanner E, Tsai JC. Glaucoma medications: use and safety in the elderly population. Drugs Aging 2006;23:321-32
   PubMed Web of Science ®Google Scholar
• Holló G, Bozkurt B, Irkec M. Brinzolamide/timolol fixed combination: a new ocular suspension for the treatment of open-angle glaucoma and ocular hypertension. Expert Opin Pharmacother 2009;10:2015-24
   PubMed Web of Science ®Google Scholar
• Holló G, Hommer A, Antón López A, Ropo A. Efficacy, safety, and tolerability of preservative-free fixed combination of tafluprost 0.0015%/timolol 0.5% versus concomitant use of the ingredients. J Ocul Pharmacol Ther 2014;30:468-75
   PubMed Web of Science ®Google Scholar
• Pfeiffer N, Traverso CE, Lorenz K, et al. A 6-month study comparing efficacy, safety, and tolerability of the preservative-free fixed combination of tafluprost 0.0015% and timolol 0.5% versus each of its individual preservative-free components. Adv Ther 2014;31:1228-46
   PubMed Web of Science ®Google Scholar
• Holló G, Vuorinen J, Tuominen J, et al. Fixed-dose combination of tafluprost and timolol in the treatment of open-angle glaucoma and ocular hypertension: comparison with other fixed-combination products. Adv Ther 2014;31:932-44
   PubMed Web of Science ®Google Scholar
• Rasmussen CA, Kaufman PL, Kiland JA. Benzalkonium chloride and glaucoma. J Ocul Pharmacol Ther 2014;30:163-9
   PubMed Web of Science ®Google Scholar
• Baudouin C, Labbé A, Liang H, et al. Preservatives in eye drops: the good, the bad and the ugly. Prog Retin Eye Res 2010;29:312-34
   PubMed Web of Science ®Google Scholar
• Rossi GC, Pasinetti GM, Scudeller L, et al. Risk factors to develop ocular surface disease in treated glaucoma or ocular hypertension patients. Eur J Ophthalmol 2013;23:296-302
   PubMed Web of Science ®Google Scholar
• Baudouin C, Renard JP, Nordmann JP, et al. Prevalence and risk factors for ocular surface disease among patients treated over the long term for glaucoma or ocular hypertension. Eur J Ophthalmol 2013;23:47-54
   Web of Science ®Google Scholar
• Fechtner RD, Godfrey DG, Budenz D, et al. Prevalence of ocular surface complaints in patients with glaucoma using topical intraocular pressure-lowering medications. Cornea 2010;29:618-21
   PubMed Web of Science ®Google Scholar
• Batra R, Tailor R, Mohamed S. Ocular surface disease exacerbated glaucoma: optimizing the ocular surface improves intraocular pressure control. J Glaucoma 2014;23:56-60
   PubMed Web of Science ®Google Scholar
• Stewart WC, Stewart JA, Nelson LA. Ocular surface disease in patients with ocular hypertension and glaucoma. Curr Eye Res 2011;36:391-8
   PubMed Web of Science ®Google Scholar
• Leung EW, Medeiros FA, Weinreb RN. Prevalence of ocular surface disease in glaucoma patients. J Glaucoma 2008;7:350-5
   Google Scholar
• Horsley MB, Kahook MY. Effects of prostaglandin analog therapy on the ocular surface of glaucoma patients. Clin Ophthalmol 2009;3:291-5
   PubMedGoogle Scholar
• Rossi GC, Pasinetti GM, Scudeller L, Bianchi PE. Ocular surface disease and glaucoma: how to evaluate impact on quality of life. J Ocul Pharmacol Ther 2013;29:390-4
   PubMed Web of Science ®Google Scholar
• Mathews PM, Ramulu PY, Friedman DS, et al. Evaluation of ocular surface disease in patients with glaucoma. Ophthalmology 2013;120:2241-8
   PubMed Web of Science ®Google Scholar
• Sarkar J, Chaudhary S, Namavari A, et al. Corneal neurotoxicity due to topical benzalkonium chloride. Invest Ophthalmol Vis Sci 2012;53:1792-802
   PubMed Web of Science ®Google Scholar
• Martone G, Frezzotti P, Tosi GM, et al. An in vivo confocal microscopy analysis of effects of topical antiglaucoma therapy with preservative on corneal innervation and morphology. Am J Ophthalmol 2009;147:725-35
   PubMed Web of Science ®Google Scholar
• Rossi GC, Tinelli C, Pasinetti GM, et al. Dry eye syndrome-related quality of life in glaucoma patients. Eur J Ophthalmol 2009;19:572-9
   PubMed Web of Science ®Google Scholar
• Skalicky SE, Goldberg I, McCluskey P. Ocular surface disease and quality of life in patients with glaucoma. Am J Ophthalmol 2012;153:1-9
   PubMed Web of Science ®Google Scholar
• Fernandez Lopez E, Karaca EE, Ekici F, et al. Symptoms reported by patients with varying stages of glaucoma: review of 401 cases. Can J Ophthalmol 2014;49:420-5
   PubMed Web of Science ®Google Scholar
• Erb C, Gast U, Schremmer D. German register for glaucoma patients with dry eye. I. Basic outcome with respect to dry eye. Graefes Arch Clin Exp Ophthalmol 2008;246:1593-601
   PubMed Web of Science ®Google Scholar
• Pisella PJ, Pouliquen P, Baudouin C. Prevalence of ocular symptoms and signs with preserved and preservative free glaucoma medication. Br J Ophthalmol 2002;86:418-23
   PubMed Web of Science ®Google Scholar
• Boimer C, Birt CM. Preservative exposure and surgical outcomes in glaucoma patients: the PESO study. J Glaucoma 2013;22:730-5
   PubMed Web of Science ®Google Scholar
• Jaenen N, Baudouin C, Pouliquen P, et al. Ocular symptoms and signs with preserved and preservative-free glaucoma medications. Eur J Ophthalmol 2007;17:341-9
   PubMed Web of Science ®Google Scholar
• Stalmans I, Sunaric Mégevand G, Cordeiro MF, et al. Preservative-free treatment in glaucoma: who, when, and why. Eur J Ophthalmol 2013;23:518-25
   PubMed Web of Science ®Google Scholar
• Liang H, Pauly A, Riancho L, et al. Toxicological evaluation of preservative-containing and preservative-free topical prostaglandin analogues on a three-dimensional-reconstituted corneal epithelium system. Br J Ophthalmol 2011;95:869-75
   PubMed Web of Science ®Google Scholar
• Rossi GC, Blini M, Scudeller L, et al. Effect of preservative-free tafluprost on keratocytes, sub-basal nerves, and endothelium: a single-blind one-year confocal study on naïve or treated glaucoma and hypertensive patients versus a control group. J Ocul Pharmacol Ther 2013;29:821-5
   PubMed Web of Science ®Google Scholar
• Frezzotti P, Fogagnolo P, Haka G, et al. In vivo confocal microscopy of conjunctiva in preservative-free timolol 0.1% gel formulation therapy for glaucoma. Acta Ophthalmol 2014;92:e133-40
   PubMed Web of Science ®Google Scholar
• Holló G. The side effects of the prostaglandin analogues. Expert Opin Drug Saf 2007;6:45-52
   PubMed Web of Science ®Google Scholar
• Alm A, Grierson I, Shields MB. Side effects associated with prostaglandin analog therapy. Surv Ophthalmol 2008;53:S93-S105
   PubMed Web of Science ®Google Scholar
• Inoue K, Shiokawa M, Higa R, et al. Adverse periocular reactions to five types of prostaglandin analogs. Eye (Lond) 2012;26:1465-72
   PubMed Web of Science ®Google Scholar
• Taketani Y, Yamagishi R, Fujishiro T, et al. Activation of the prostanoid FP receptor inhibits adipogenesis leading to deepening of the upper eyelid sulcus in prostaglandin-associated periorbitopathy. Invest Ophthalmol Vis Sci 2014;55:1269-76
   PubMed Web of Science ®Google Scholar
• Kucukevcilioglu M, Bayer A, Uysal Y, Altinsoy HI. Prostaglandin associated periorbitopathy in patients using bimatoprost, latanoprost and travoprost. Clin Experiment Ophthalmol 2014;42:126-31
   PubMed Web of Science ®Google Scholar
• Inoue K, Shiokawa M, Wakakura M, Tomita G. Deepening of the upper eyelid sulcus caused by 5 types of prostaglandin analogs. J Glaucoma 2013;22:626-31
   PubMed Web of Science ®Google Scholar
• Cracknell KP, Grierson I. Prostaglandin analogues in the anterior eye: their pressure lowering action and side effects. Exp Eye Res 2009;88:786-91
   PubMed Web of Science ®Google Scholar
• Maruyama Y, Mori K, Ikeda Y, et al. Effects of long-term topical prostaglandin therapy on central corneal thickness. J Ocul Pharmacol Ther 2014;30:440-4
   PubMed Web of Science ®Google Scholar
• Sakata R, Shirato S, Miyata K, Aihara M. Incidence of deepening of the upper eyelid sulcus on treatment with a tafluprost ophthalmic solution. Jpn J Ophthalmol 2014;58:212-17
   PubMed Web of Science ®Google Scholar
• Yoshino T, Fukuchi T, Togano T, et al. Eyelid and eyelash changes due to prostaglandin analog therapy in unilateral treatment cases. Jpn J Ophthalmol 2013;57:172-8
   PubMed Web of Science ®Google Scholar
• Panos GD, Konstantinidis A, Mendrinos E, et al. Effect of tafluprost 0.0015% on central corneal thickness in patients with primary open-angle glaucoma. Curr Eye Res 2013;38:977-82
   PubMed Web of Science ®Google Scholar
• Suzuki K, Teranishi S, Sagara T, et al. Safety and efficacy of benzalkonium chloride-optimized tafluprost in Japanese glaucoma patients with existing superficial punctate keratitis. J Glaucoma 2013;10.1097/IJG.0000000000000020. [ Epub ahead of print]
   Google Scholar
• Kumagami T, Wakiyama H, Kusano M, et al. Comparison of corneal safety and intraocular pressure-lowering effect of tafluprost ophthalmic solution with other prostaglandin ophthalmic solutions. J Ocul Pharmacol Ther 2014;30:340-5
   PubMed Web of Science ®Google Scholar
• Uusitalo H, Pillunat LE, Ropo A; Phase III Study Investigators. Efficacy and safety of tafluprost 0.0015% versus latanoprost 0.005% eye drops in open-angle glaucoma and ocular hypertension: 24-month results of a randomized, double-masked phase III study. Acta Ophthalmol 2010;88:12-19
   PubMed Web of Science ®Google Scholar
• Konstas AG, Quaranta L, Katsanos A, et al. Twenty-four hour efficacy with preservative free tafluprost compared with latanoprost in patients with primary open angle glaucoma or ocular hypertension. Br J Ophthalmol 2013;97:1510-15
   PubMed Web of Science ®Google Scholar
• Chabi A, Varma R, Tsai JC, et al. Randomized clinical trial of the efficacy and safety of preservative-free tafluprost and timolol in patients with open-angle glaucoma or ocular hypertension. Am J Ophthalmol 2012;153:1187-96
   PubMed Web of Science ®Google Scholar
• Milla E, Stirbu O, Rey A, et al. Spanish multicenter tafluprost tolerability study. Br J Ophthalmol 2012;96:826-31
   PubMed Web of Science ®Google Scholar
• Uusitalo H, Chen E, Pfeiffer N, et al. Switching from a preserved to a preservative-free prostaglandin preparation in topical glaucoma medication. Acta Ophthalmol 2010;88:329-36
   PubMed Web of Science ®Google Scholar
• Schnober D, Hofmann G, Maier H, et al. Diurnal IOP-lowering efficacy and safety of travoprost 0.004% compared with tafluprost 0.0015% in patients with primary open-angle glaucoma or ocular hypertension. Clin Ophthalmol 2010;4:1459-63
   PubMedGoogle Scholar
• Erb C, Lanzl I, Seidova SF, Kimmich F. Preservative-free tafluprost 0.0015% in the treatment of patients with glaucoma and ocular hypertension. Adv Ther 2011;28:575-85
   PubMed Web of Science ®Google Scholar
• Lanzl I, Hamacher T, Rosbach K, et al. Preservative-free tafluprost in the treatment of naive patients with glaucoma and ocular hypertension. Clin Ophthalmol 2013;7:901-10
   PubMedGoogle Scholar
• Hommer A, Mohammed Ramez O, Burchert M, Kimmich F. IOP-lowering efficacy and tolerability of preservative-free tafluprost 0.0015% among patients with ocular hypertension or glaucoma. Curr Med Res Opin 2010;26:1905-13
   PubMed Web of Science ®Google Scholar
• Brasnu E, Brignole-Baudouin F, Riancho L, et al. In vitro effects of preservative-free tafluprost and preserved latanoprost, travoprost, and bimatoprost in a conjunctival epithelial cell line. Curr Eye Res 2008;33:303-12
   PubMed Web of Science ®Google Scholar
• Tanna AP, Rademaker AW, Stewart WC, Feldman RM. Meta-analysis of the efficacy and safety of alpha2-adrenergic agonists, beta-adrenergic antagonists, and topical carbonic anhydrase inhibitors with prostaglandin analogs. Arch Ophthalmol 2010;128:825-33
   PubMed Web of Science ®Google Scholar
• Ramdas WD, van der Velde N, van der Cammen TJ, Wolfs RC. Evaluation of risk of falls and orthostatic hypotension in older, long-term topical beta-blocker users. Graefes Arch Clin Exp Ophthalmol 2009;247:1235-41
   PubMed Web of Science ®Google Scholar
• Müskens RP, Wolfs RC, Witteman JC. Topical Beta blockers and mortality. Ophthalmology 2008;115:2037-43
   PubMed Web of Science ®Google Scholar
• Iester M, Telani S, Frezzotti P, et al. Ocular surface changes in glaucomatous patients treated with and without preservatives beta-blockers. J Ocul Pharmacol Ther 2014;30:476-81
   PubMed Web of Science ®Google Scholar
• Egorov E, Ropo A; Investigators. Adjunctive use of tafluprost with timolol provides additive effects for reduction of intraocular pressure in patients with glaucoma. Eur J Ophthalmol 2009;19:214-22
   PubMed Web of Science ®Google Scholar
• Lorenz K, Pfeiffer N. Efficacy and safety of tafluprost 0.0015% and timolol maleate 0.5% fixed combination in patients with ocular hypertension or open-angle glaucoma. Expert Opin Pharmacother 2014;15:2255-62
   PubMed Web of Science ®Google Scholar
• Hughes BA, Bacharach J, Craven ER, et al. A three- month, multicenter, double-masked study of the safety and efficacy of travoprost 0.004%/timolol 0.5% ophthalmic solution compared to travoprost 0.004% ophthalmic solution and timolol 0.5% dosed concomitantly in subjects with open angle glaucoma or ocular hypertension. J Glaucoma 2005;14:392-9
   PubMed Web of Science ®Google Scholar
• Schuman JS, Katz GJ, Lewis RA, et al. Efficacy and safety of a fixed combination of travoprost 0.004%/timolol 0.5% ophthalmic solution once daily for open-angle glaucoma or ocular hypertension. Am J Ophthalmol 2005;140:242-50
   PubMed Web of Science ®Google Scholar
• Barnebey HS, Orengo-Nania S, Flowers BE, et al. The safety and efficacy of travoprost 0.004%/timolol 0.5% fixed combination ophthalmic solution. Am J Ophthalmol 2005;140:1-7
   PubMed Web of Science ®Google Scholar
• Topouzis F, Melamed S, Danesh-Meyer H, et al. A 1-year study to compare the efficacy and safety of once-daily travoprost 0.004%/timolol 0.5% to once-daily latanoprost 0.005%/timolol 0.5% in patients with open-angle glaucoma or ocular hypertension. Eur J Ophthalmol 2007;17:183-90
   PubMed Web of Science ®Google Scholar
• Kitazawa Y, Smith P, Sasaki N, et al. Travoprost 0.004%/timolol 0.5%-fixed combination with and without benzalkonium chloride: a prospective, randomized, doubled- masked comparison of safety and efficacy. Eye (Lond) 2011;25:1161-9
   PubMed Web of Science ®Google Scholar
• Brandt JD, Cantor LB, Katz LJ, et al. Bimatoprost/timolol fixed combination: a 3-month double-masked, randomized parallel comparison to its individual components in patients with glaucoma or ocular hypertension. J Glaucoma 2008;17:211-16
   PubMed Web of Science ®Google Scholar
• Lewis RA, Gross RL, Sall KN, et al. The safety and efficacy of bimatoprost/timolol fixed combination: a 1-year double-masked, randomized, parallel comparison to its individual components in patients with glaucoma or ocular hypertension. J Glaucoma 2010;19:424-6
   PubMed Web of Science ®Google Scholar
• Goldberg I, Gil Pina R, Lanzagorta-Aresti A, et al. Bimatoprost 0.03%/timolol 0.5% preservative-free ophthalmic solution versus bimatoprost 0.03%/timolol 0.5% (Ganfort®) for glaucoma or ocular hypertension: a 12-week randomized controlled trial. Br J Ophthalmol 2014;98:926-31
   PubMed Web of Science ®Google Scholar
• Diestelhorst M, Larsson LI; European-Canadian Latanoprost Fixed Combination Study Group. A 12-week, randomized, double-masked, multicenter study of the fixed combination of latanoprost and timolol in the evening versus the individual components. Ophthalmology 2006;113:70-6
   PubMed Web of Science ®Google Scholar
• Higginbotham EJ, Olander KW, Kim EE, et al. Fixed combination of latanoprost and timolol vs. individual components for primary open-angle glaucoma or ocular hypertension: a randomized, double-masked study. Arch Ophthalmol 2010;128:165-72
   PubMed Web of Science ®Google Scholar
• Palmberg P, Kim EE, Kwok KK, et al. A 12-week, randomized, double-masked study of fixed combination latanoprost/timolol versus latanoprost or timolol monotherapy. Eur J Ophthalmol 2010;20:708-18
   PubMed Web of Science ®Google Scholar
• Holló G, Ropo A. Intraocular pressure decrease with preservative-free fixed and unfixed combination of tafluprost and timolol in pseudoexfoliative glaucoma. Curr Med Res Opin 2015;31(1):13-16
   PubMed Web of Science ®Google Scholar
• Dietlein TS, Jordan JF, Lüke C, et al. Self-application of single-use eye drop containers in an elderly population: comparisons with standard eye drop bottle and with younger patients. Acta Ophthalmol 2008;86:856-9
   PubMed Web of Science ®Google Scholar
• Parkkari M, Latvala T, Ropo A. Handling test of eye drop dispenser-comparison of unit-dose pipettes with conventional eye drop bottles. J Ocul Pharmacol Ther 2010;26:273-6
   PubMed Web of Science ®Google Scholar