Efficacy and safety of topical BAK-free travoprost 0.004% versus BAK-preserved travoprost 0.004% in the treatment of primary open angle glaucoma: a comparative study at a tertiary care hospital
Keywords:BAK, BAK-free travoprost, Intraocular pressure, OSDI, Ocular surface disease index, Primary open angle glaucoma
Background: Prostaglandin analogues (PGAs) reduce intraocular pressure (IOP) in patients with primary open-angle glaucoma (POAG); however, these medications may affect the ocular surface and elicit ocular discomfort when preserved with benzalkonium chloride (BAK). Hence the above study was taken to evaluate the benefit of BAK-free formulations of travoprost. The objectives of the study were to compare the efficacy, safety of topical BAK-free travoprost 0.004% versus BAK-preserved travoprost 0.004% in patients with primary open angle glaucoma.
Methods: 40 patients with POAG who fulfilled the inclusion /exclusion criteria were randomised into two groups of 20 each to receive BAK-free travoprost 0.004% or BAK-preserved travoprost once daily in the evening. Efficacy was measured in terms of reduction in IOP monitored at 4, 8 and 12 weeks from baseline. Ocular surface disease index (OSDI) questionnaire was used to assess the ocular surface symptoms. Safety was assessed by monitoring treatment emergent adverse drug reactions (ADRs).
Results: Both the study medications were effective in reducing IOP when compared to baseline. Mean IOP reduction from baseline to week 12 was 11±3mmHg (p <0.001), 10.78±3.01mmHg, (p<0.001) in BAK-free travoprost and BAK-preserved travoprost groups respectively. Both produced equivalent reductions in IOP at the end of 4 (7.89±1.82 vs 7.63±2.83, p=0.72), 8 (9.94±2.75 vs10.05±2.75, p=0.90), and 12 weeks (11±3 vs10.78±3.01, p=0.82). BAK-free travoprost demonstrated significantly lower OSDI scores (15.10±3.60) compared to BAK- preserved travoprost (23.47±7.10) at 12 weeks (p <0.0001). There was no significant difference in occurrence of conjunctival hyperaemia between the study drugs (c2 = 0, df = 1, p = 1) and BAK-free travoprost was well tolerated.
Conclusions: BAK-free and BAK-preserved travoprost significantly reduced IOP at 12 weeks. But, BAK- free travoprost produced significantly less ocular surface symptoms as compared to BAK- preserved travoprost. Hence it could be a favourable option in POAG patients with ocular surface disease symptoms.
Eyawo O, Nachega J, Lefebvre P, Meyer D, Rachlis B, Lee CW, et al. Efficacy and safety of prostaglandin analogues in patients with predominantly primary open-angle glaucoma or ocular hypertension: a meta-analysis. Clin Ophthalmol. 2009;3:447-56.
Sambhara D, Aref AA. Glaucoma management: relative value and place in therapy of available drug treatments. Therapeutic Advances in Chronic Disease. 2014;5(1):30-43.
Sinha SK, Astbury N. Evaluation of the effectiveness of ophthalmic assistants as screeners for glaucoma in North India. Eye. 2011;25(10):1310-6.
Denis P, Covert D, Realini A. Travoprost in the management of open-angle glaucoma and ocular hypertension. Clinical ophthalmology. 2007;1(1):11-24.
Kaštelan S, Tomić M, Metež Soldo K, Salopek-Rabatić J. How ocular surface disease impacts the glaucoma treatment outcome. BioMed research international. 2013 Oct 9;2013.
Yuksel N. Evaluation of Ocular Surface Disease Associated with Glaucoma Patients. European Ophthalmic Review. 2013;7(2):81-3.
Cvenkel B, Stunf S, Kirbis SI, Flezar SM. Symptoms and signs of ocular surface disease related to topical medication in patients with glaucoma. Clinical Ophthalmology. 2015;9:625-31.
Henry JC, Peace JH, Stewart JA, Stewart WC. Efficacy, safety, and improved tolerability of travoprost BAK-free ophthalmic solution compared with prior prostaglandin therapy. Clinical ophthalmology. 2008;2(3):613-21.
Mirza, Sophia K, Johnson SM. Efficacy and Patient Tolerability of Travoprost BAK-Free Solution in Patients with Open-Angle Glaucoma and Ocular Hypertension. Clinical Ophthalmology. 2010:877-88.
Fechtner RD, Godfrey DG, Budenz D, Stewart JA, Stewart WC, Jasek MC. Prevalence of ocular surface complaints in patients with glaucoma using topical intraocular pressure-lowering medications. Cornea. 2010;29:618-21.
Walt J, Rowe M, Stern K. Evaluating the functional impact of dry eye: The Ocular Surface Disease Index. Drug Inf J. 1997;31:1436
Lopes JF, Hubatsch DA, Amaris P. Effect of benzalkonium chloride–free travoprost on intraocular pressure and ocular surface symptoms in patients with glaucoma previously on latanoprost: an open-label study. BMC Ophthalmology. 2015;15:166.
Herreras JM, Pastor JC, Calonge M, Asensio VM. Ocular surface alteration after long-term treatment with an antiglaucomatous drug. Ophthalmology. 1992;99:1082-8.
Turacli E, Budak K, Kaur A, Mizrak B, Ekinci C. The effects of long-term topical glaucoma medication on conjunctival impression cytology. Int Ophthalmol. 1997;21:27-33.
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.
Lewis RA, Katz GJ, Weiss MJ, Landry TA, Dickerson JE, James JE, et al. Travoprost 0.004% with and without benzalkonium chloride: a comparison of safety and efficacy. J Glaucoma. 2007;16(1):98-103.
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 Jan-Feb;22(1):34-44.
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.