Skip to main content
Top
Published in: BMC Ophthalmology 1/2015

Open Access 01-12-2015 | Research article

Effect of benzalkonium chloride–free travoprost on intraocular pressure and ocular surface symptoms in patients with glaucoma previously on latanoprost: an open-label study

Authors: Joao F. Lopes, Douglas A. Hubatsch, Patricia Amaris

Published in: BMC Ophthalmology | Issue 1/2015

Login to get access

Abstract

Background

Prostaglandin analogs reduce intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension; however, these medications may affect the ocular surface and elicit ocular discomfort when preserved with benzalkonium chloride (BAK).

Methods

This was an open-label, single-arm study conducted in Latin America from February 2012 to May 2013. Patients with open-angle glaucoma or ocular hypertension who were intolerant of latanoprost 0.005 % were transitioned to receive once-daily BAK-free travoprost 0.004 % containing polyquaternium-1 (Travatan® preserved with POLYQUAD® [PQ], Alcon Laboratories, Inc; Fort Worth, TX) for 12 weeks. Mean change in IOP from baseline (primary efficacy endpoint) and the percentage of patients who achieved a target IOP of ≤18 mmHg were evaluated at all on-therapy visits. Ocular hyperemia, patient preference, and self-projected adherence were assessed at week 12. Adverse events (AEs) were monitored throughout the study.

Results

All enrolled patients were included in the analysis (n = 191); the majority of patients (90.6 %, n = 173/191) completed the study. Mean (SD) patient age was 67.5 (11.3) years, and mean baseline IOP was 14.8 mmHg. Mean IOP was reduced by 0.94 mmHg at week 6 and by 1.09 mmHg at week 12 (P < 0.001 for both). A greater percentage of patients achieved a target IOP of ≤18 mmHg at week 6 (93.1 %; n = 163/175) and week 12 (93.3 %; n = 166/178) compared with baseline (89.5 %; n = 171/191). There was a 10.5 % increase in the percentage of patients with “none/trace” amounts of hyperemia. Most patients preferred the study medication (81.5 %; n = 141/173) and were confident that they would adhere to their preferred medication (90.8 %; n = 157/173). No serious AEs were reported, and eye irritation (3.7 %; n = 7/191) was the most common treatment-related AE.

Conclusions

Transitioning from BAK-containing latanoprost 0.005 % to BAK-free travoprost 0.004 % preserved with PQ reduced IOP in patients with open-angle glaucoma or ocular hypertension who were intolerant of latanoprost. BAK-free travoprost 0.004 % is a viable alternative for patients who require switching their IOP-lowering medications because of tolerability issues.

Trial registration

ClinicalTrials.gov identifier, NCT01510145
Literature
1.
go back to reference Casson RJ, Chidlow G, Wood JP, Crowston JG, Goldberg I. Definition of glaucoma: clinical and experimental concepts. Clin Experiment Ophthalmol. 2012;40(4):341–9.CrossRefPubMed Casson RJ, Chidlow G, Wood JP, Crowston JG, Goldberg I. Definition of glaucoma: clinical and experimental concepts. Clin Experiment Ophthalmol. 2012;40(4):341–9.CrossRefPubMed
3.
go back to reference Grigera DE, Mello PA, Barbosa WL, Casiraghi JF, Grossmann RP, Peyret A. Level of agreement among Latin American glaucoma subspecialists on the diagnosis and treatment of glaucoma: results of an online survey. Arq Bras Oftalmol. 2013;76(3):163–9.CrossRefPubMed Grigera DE, Mello PA, Barbosa WL, Casiraghi JF, Grossmann RP, Peyret A. Level of agreement among Latin American glaucoma subspecialists on the diagnosis and treatment of glaucoma: results of an online survey. Arq Bras Oftalmol. 2013;76(3):163–9.CrossRefPubMed
4.
go back to reference Collaborative Normal-Tension Glaucoma Study Group. The effectiveness of intraocular pressure reduction in the treatment of normal-tension glaucoma. Am J Ophthalmol. 1998;126(4):498–505.CrossRef Collaborative Normal-Tension Glaucoma Study Group. The effectiveness of intraocular pressure reduction in the treatment of normal-tension glaucoma. Am J Ophthalmol. 1998;126(4):498–505.CrossRef
5.
go back to reference The Advanced Glaucoma Intervention Study (AGIS) Investigators. The Advanced Glaucoma Intervention Study (AGIS): 7. The relationship between control of intraocular pressure and visual field deterioration. Am J Ophthalmol. 2000;130(4):429–40.CrossRef The Advanced Glaucoma Intervention Study (AGIS) Investigators. The Advanced Glaucoma Intervention Study (AGIS): 7. The relationship between control of intraocular pressure and visual field deterioration. Am J Ophthalmol. 2000;130(4):429–40.CrossRef
6.
go back to reference Watanabe K, Chiou GC. Action mechanism of timolol to lower the intraocular pressure in rabbits. Ophthalmic Res. 1983;15(3):160–7.CrossRefPubMed Watanabe K, Chiou GC. Action mechanism of timolol to lower the intraocular pressure in rabbits. Ophthalmic Res. 1983;15(3):160–7.CrossRefPubMed
7.
go back to reference Toris CB, Zhan G, Fan S, Dickerson JE, Landry TA, Bergamini MV, et al. Effects of travoprost on aqueous humor dynamics in patients with elevated intraocular pressure. J Glaucoma. 2007;16(2):189–95.CrossRefPubMed Toris CB, Zhan G, Fan S, Dickerson JE, Landry TA, Bergamini MV, et al. Effects of travoprost on aqueous humor dynamics in patients with elevated intraocular pressure. J Glaucoma. 2007;16(2):189–95.CrossRefPubMed
8.
go back to reference Webers CA, Beckers HJ, Nuijts RM, Schouten JS. Pharmacological management of primary open-angle glaucoma: second-line options and beyond. Drugs Aging. 2008;25(9):729–59.CrossRefPubMed Webers CA, Beckers HJ, Nuijts RM, Schouten JS. Pharmacological management of primary open-angle glaucoma: second-line options and beyond. Drugs Aging. 2008;25(9):729–59.CrossRefPubMed
9.
go back to reference van der Valk R, Webers CA, Schouten JS, Zeegers MP, Hendrikse F, Prins MH. Intraocular pressure-lowering effects of all commonly used glaucoma drugs: a meta-analysis of randomized clinical trials. Ophthalmology. 2005;112(7):1177–85.CrossRefPubMed van der Valk R, Webers CA, Schouten JS, Zeegers MP, Hendrikse F, Prins MH. Intraocular pressure-lowering effects of all commonly used glaucoma drugs: a meta-analysis of randomized clinical trials. Ophthalmology. 2005;112(7):1177–85.CrossRefPubMed
10.
go back to reference Bauer K, Brunner-Ferber F, Distlerath LM, Lippa EA, Binkowitz B, Till P, et al. Assessment of systemic effects of different ophthalmic beta-blockers in healthy volunteers. Clin Pharmacol Ther. 1991;49(6):658–64.CrossRefPubMed Bauer K, Brunner-Ferber F, Distlerath LM, Lippa EA, Binkowitz B, Till P, et al. Assessment of systemic effects of different ophthalmic beta-blockers in healthy volunteers. Clin Pharmacol Ther. 1991;49(6):658–64.CrossRefPubMed
11.
go back to reference Javitt JC, Schiffman RM. Clinical success and quality of life with brimonidine 0.2 % or timolol 0.5 % used twice daily in glaucoma or ocular hypertension: a randomized clinical trial. Brimonidine Outcomes Study Group I. J Glaucoma. 2000;9(3):224–34.CrossRefPubMed Javitt JC, Schiffman RM. Clinical success and quality of life with brimonidine 0.2 % or timolol 0.5 % used twice daily in glaucoma or ocular hypertension: a randomized clinical trial. Brimonidine Outcomes Study Group I. J Glaucoma. 2000;9(3):224–34.CrossRefPubMed
12.
go back to reference Kass MA, Gordon MO, Hoff MR, Parkinson JM, Kolker AE, Hart WM Jr, et al. Topical timolol administration reduces the incidence of glaucomatous damage in ocular hypertensive individuals. A randomized, double-masked, long-term clinical trial. Arch Ophthalmol. 1989;107(11):1590–8.CrossRefPubMed Kass MA, Gordon MO, Hoff MR, Parkinson JM, Kolker AE, Hart WM Jr, et al. Topical timolol administration reduces the incidence of glaucomatous damage in ocular hypertensive individuals. A randomized, double-masked, long-term clinical trial. Arch Ophthalmol. 1989;107(11):1590–8.CrossRefPubMed
13.
go back to reference Uusitalo H, Kahonen M, Ropo A, Maenpaa J, Bjarnhall G, Hedenstrom H, et al. Improved systemic safety and risk-benefit ratio of topical 0.1 % timolol hydrogel compared with 0.5 % timolol aqueous solution in the treatment of glaucoma. Graefes Arch Clin Exp Ophthalmol. 2006;244(11):1491–6.CrossRefPubMed Uusitalo H, Kahonen M, Ropo A, Maenpaa J, Bjarnhall G, Hedenstrom H, et al. Improved systemic safety and risk-benefit ratio of topical 0.1 % timolol hydrogel compared with 0.5 % timolol aqueous solution in the treatment of glaucoma. Graefes Arch Clin Exp Ophthalmol. 2006;244(11):1491–6.CrossRefPubMed
14.
go back to reference Waldock A, Snape J, Graham CM. Effects of glaucoma medications on the cardiorespiratory and intraocular pressure status of newly diagnosed glaucoma patients. Br J Ophthalmol. 2000;84(7):710–3.CrossRefPubMedPubMedCentral Waldock A, Snape J, Graham CM. Effects of glaucoma medications on the cardiorespiratory and intraocular pressure status of newly diagnosed glaucoma patients. Br J Ophthalmol. 2000;84(7):710–3.CrossRefPubMedPubMedCentral
15.
go back to reference Parrish RK, Palmberg P, Sheu WP, Group XLTS. A comparison of latanoprost, bimatoprost, and travoprost in patients with elevated intraocular pressure: a 12-week, randomized, masked-evaluator multicenter study. Am J Ophthalmol. 2003;135(5):688–703.CrossRefPubMed Parrish RK, Palmberg P, Sheu WP, Group XLTS. A comparison of latanoprost, bimatoprost, and travoprost in patients with elevated intraocular pressure: a 12-week, randomized, masked-evaluator multicenter study. Am J Ophthalmol. 2003;135(5):688–703.CrossRefPubMed
16.
go back to reference Aptel F, Cucherat M, Denis P. Efficacy and tolerability of prostaglandin analogs: a meta-analysis of randomized controlled clinical trials. J Glaucoma. 2008;17(8):667–73.CrossRefPubMed Aptel F, Cucherat M, Denis P. Efficacy and tolerability of prostaglandin analogs: a meta-analysis of randomized controlled clinical trials. J Glaucoma. 2008;17(8):667–73.CrossRefPubMed
17.
go back to reference Riva I, Katsanos A, Floriani I, Biagioli E, Konstas AG, Centofanti M, et al. Long-term 24-hour intraocular pressure control with travoprost monotherapy in patients with primary open-angle glaucoma. J Glaucoma. 2014;23(8):535–40.CrossRefPubMed Riva I, Katsanos A, Floriani I, Biagioli E, Konstas AG, Centofanti M, et al. Long-term 24-hour intraocular pressure control with travoprost monotherapy in patients with primary open-angle glaucoma. J Glaucoma. 2014;23(8):535–40.CrossRefPubMed
18.
go back to reference Kaur IP, Lal S, Rana C, Kakkar S, Singh H. Ocular preservatives: associated risks and newer options. Cutan Ocul Toxicol. 2009;28(3):93–103.CrossRefPubMed Kaur IP, Lal S, Rana C, Kakkar S, Singh H. Ocular preservatives: associated risks and newer options. Cutan Ocul Toxicol. 2009;28(3):93–103.CrossRefPubMed
19.
go back to reference Jaenen N, Baudouin C, Pouliquen P, Manni G, Figueiredo A, Zeyen T. Ocular symptoms and signs with preserved and preservative-free glaucoma medications. Eur J Ophthalmol. 2007;17(3):341–9.PubMed Jaenen N, Baudouin C, Pouliquen P, Manni G, Figueiredo A, Zeyen T. Ocular symptoms and signs with preserved and preservative-free glaucoma medications. Eur J Ophthalmol. 2007;17(3):341–9.PubMed
20.
go back to reference Kuppens EV, de Jong CA, Stolwijk TR, de Keizer RJ, van Best JA. Effect of timolol with and without preservative on the basal tear turnover in glaucoma. Br J Ophthalmol. 1995;79(4):339–42.CrossRefPubMedPubMedCentral Kuppens EV, de Jong CA, Stolwijk TR, de Keizer RJ, van Best JA. Effect of timolol with and without preservative on the basal tear turnover in glaucoma. Br J Ophthalmol. 1995;79(4):339–42.CrossRefPubMedPubMedCentral
21.
go back to reference Pisella PJ, Pouliquen P, Baudouin C. Prevalence of ocular symptoms and signs with preserved and preservative free glaucoma medication. Br J Ophthalmol. 2002;86(4):418–23.CrossRefPubMedPubMedCentral Pisella PJ, Pouliquen P, Baudouin C. Prevalence of ocular symptoms and signs with preserved and preservative free glaucoma medication. Br J Ophthalmol. 2002;86(4):418–23.CrossRefPubMedPubMedCentral
22.
go back to reference Guenoun JM, Baudouin C, Rat P, Pauly A, Warnet JM, Brignole-Baudouin F. In vitro study of inflammatory potential and toxicity profile of latanoprost, travoprost, and bimatoprost in conjunctiva-derived epithelial cells. Invest Ophthalmol Vis Sci. 2005;46(7):2444–50.CrossRefPubMed Guenoun JM, Baudouin C, Rat P, Pauly A, Warnet JM, Brignole-Baudouin F. In vitro study of inflammatory potential and toxicity profile of latanoprost, travoprost, and bimatoprost in conjunctiva-derived epithelial cells. Invest Ophthalmol Vis Sci. 2005;46(7):2444–50.CrossRefPubMed
23.
go back to reference Brignole-Baudouin F, Riancho L, Liang H, Baudouin C. Comparative in vitro toxicology study of travoprost polyquad-preserved, travoprost BAK-preserved, and latanoprost BAK-preserved ophthalmic solutions on human conjunctival epithelial cells. Curr Eye Res. 2011;36(11):979–88.CrossRefPubMed Brignole-Baudouin F, Riancho L, Liang H, Baudouin C. Comparative in vitro toxicology study of travoprost polyquad-preserved, travoprost BAK-preserved, and latanoprost BAK-preserved ophthalmic solutions on human conjunctival epithelial cells. Curr Eye Res. 2011;36(11):979–88.CrossRefPubMed
24.
go back to reference Kim EJ, Kim YH, Kang SH, Lee KW, Park YJ. In vitro effects of preservative-free and preserved prostaglandin analogs on primary cultured human conjunctival fibroblast cells. Korean J Ophthalmol. 2013;27(6):446–53.CrossRefPubMedPubMedCentral Kim EJ, Kim YH, Kang SH, Lee KW, Park YJ. In vitro effects of preservative-free and preserved prostaglandin analogs on primary cultured human conjunctival fibroblast cells. Korean J Ophthalmol. 2013;27(6):446–53.CrossRefPubMedPubMedCentral
25.
go back to reference De Saint Jean M, Brignole F, Bringuier AF, Bauchet A, Feldmann G, Baudouin C. Effects of benzalkonium chloride on growth and survival of Chang conjunctival cells. Invest Ophthalmol Vis Sci. 1999;40(3):619–30.PubMed De Saint Jean M, Brignole F, Bringuier AF, Bauchet A, Feldmann G, Baudouin C. Effects of benzalkonium chloride on growth and survival of Chang conjunctival cells. Invest Ophthalmol Vis Sci. 1999;40(3):619–30.PubMed
26.
go back to reference Gandolfi S, Paredes T, Goldberg I, Coote M, Wells A, Volksone L, et al. Comparison of a travoprost BAK-free formulation preserved with polyquaternium-1 with BAK-preserved travoprost in ocular hypertension or open-angle glaucoma. Eur J Ophthalmol. 2012;22(1):34–44.CrossRefPubMed Gandolfi S, Paredes T, Goldberg I, Coote M, Wells A, Volksone L, et al. Comparison of a travoprost BAK-free formulation preserved with polyquaternium-1 with BAK-preserved travoprost in ocular hypertension or open-angle glaucoma. Eur J Ophthalmol. 2012;22(1):34–44.CrossRefPubMed
27.
go back to reference Kitazawa Y, Smith P, Sasaki N, Kotake S, Bae K, Iwamoto Y. 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(9):1161–9.CrossRef Kitazawa Y, Smith P, Sasaki N, Kotake S, Bae K, Iwamoto Y. 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(9):1161–9.CrossRef
28.
go back to reference Aihara M, Otani S, Kozaki J, Unoki K, Takeuchi M, Minami K, et al. Long-term effect of BAK-free travoprost on ocular surface and intraocular pressure in glaucoma patients after transition from latanoprost. J Glaucoma. 2012;21(1):60–4.CrossRefPubMed Aihara M, Otani S, Kozaki J, Unoki K, Takeuchi M, Minami K, et al. Long-term effect of BAK-free travoprost on ocular surface and intraocular pressure in glaucoma patients after transition from latanoprost. J Glaucoma. 2012;21(1):60–4.CrossRefPubMed
29.
go back to reference Henry JC, Peace JH, Stewart JA, Stewart WC. Efficacy, safety, and improved tolerability of travoprost BAK-free ophthalmic solution compared with prior prostaglandin therapy. Clin Ophthalmol. 2008;2(3):613–21.PubMedPubMedCentral Henry JC, Peace JH, Stewart JA, Stewart WC. Efficacy, safety, and improved tolerability of travoprost BAK-free ophthalmic solution compared with prior prostaglandin therapy. Clin Ophthalmol. 2008;2(3):613–21.PubMedPubMedCentral
30.
go back to reference Ghosh S, O’Hare F, Lamoureux E, Vajpayee RB, Crowston JG. Prevalence of signs and symptoms of ocular surface disease in individuals treated and not treated with glaucoma medication. Clin Experiment Ophthalmol. 2012;40(7):675–81.CrossRefPubMed Ghosh S, O’Hare F, Lamoureux E, Vajpayee RB, Crowston JG. Prevalence of signs and symptoms of ocular surface disease in individuals treated and not treated with glaucoma medication. Clin Experiment Ophthalmol. 2012;40(7):675–81.CrossRefPubMed
31.
go back to reference Tomic M, Kastelan S, Metez Soldo K, Salopek-Rabatic J. Influence of BAK-preserved prostaglandin analog treatment on the ocular surface health in patients with newly diagnosed primary open-angle glaucoma. Biomed Res Int. 2013;2013:603782.CrossRefPubMedPubMedCentral Tomic M, Kastelan S, Metez Soldo K, Salopek-Rabatic J. Influence of BAK-preserved prostaglandin analog treatment on the ocular surface health in patients with newly diagnosed primary open-angle glaucoma. Biomed Res Int. 2013;2013:603782.CrossRefPubMedPubMedCentral
32.
go back to reference Wilson WS, Duncan AJ, Jay JL. Effect of benzalkonium chloride on the stability of the precorneal tear film in rabbit and man. Br J Ophthalmol. 1975;59(11):667–9.CrossRefPubMedPubMedCentral Wilson WS, Duncan AJ, Jay JL. Effect of benzalkonium chloride on the stability of the precorneal tear film in rabbit and man. Br J Ophthalmol. 1975;59(11):667–9.CrossRefPubMedPubMedCentral
33.
go back to reference Gimenez-Gomez R, Garcia-Catalan MR, Gallardo-Galera JM. Tear clearance and ocular symptoms in patients treated with preservative-free prostaglandins. Arch Soc Esp Oftalmol. 2013;88(3):88–91.CrossRefPubMed Gimenez-Gomez R, Garcia-Catalan MR, Gallardo-Galera JM. Tear clearance and ocular symptoms in patients treated with preservative-free prostaglandins. Arch Soc Esp Oftalmol. 2013;88(3):88–91.CrossRefPubMed
34.
go back to reference Reardon G, Kotak S, Schwartz GF. Objective assessment of compliance and persistence among patients treated for glaucoma and ocular hypertension: a systematic review. Patient Prefer Adherence. 2011;5:441–63.CrossRefPubMedPubMedCentral Reardon G, Kotak S, Schwartz GF. Objective assessment of compliance and persistence among patients treated for glaucoma and ocular hypertension: a systematic review. Patient Prefer Adherence. 2011;5:441–63.CrossRefPubMedPubMedCentral
Metadata
Title
Effect of benzalkonium chloride–free travoprost on intraocular pressure and ocular surface symptoms in patients with glaucoma previously on latanoprost: an open-label study
Authors
Joao F. Lopes
Douglas A. Hubatsch
Patricia Amaris
Publication date
01-12-2015
Publisher
BioMed Central
Published in
BMC Ophthalmology / Issue 1/2015
Electronic ISSN: 1471-2415
DOI
https://doi.org/10.1186/s12886-015-0151-7

Other articles of this Issue 1/2015

BMC Ophthalmology 1/2015 Go to the issue