Efficacy and tolerability of benzalkonium chloride-free travoprost in glaucoma patients switched from benzalkonium chloride-preserved latanoprost or bimatoprost

Julian García-Feijoo,¹ Francisco J Muñoz-Negrete,² Douglas A Hubatsch,³ Gemma C Rossi⁴

On behalf of the study investigators

¹Department of Ophthalmology, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos, Universidad Complutense, OFTARED, ²Hospital UniversItario Ramón y Cajal, Universidad de Alcalá, IRYCIS, OFTARED, Madrid, Spain; ³Alcon Laboratories, Inc., Fort Worth, TX, USA; ⁴Department of Ophthalmology, University Eye Clinic, IRCCS Policlinico San Matteo Foundation, Pavia, Italy

Introduction: The preservative benzalkonium chloride (BAK) is used to preserve several topical, intraocular pressure (IOP)-lowering glaucoma medications but can cause tolerability concerns that may lead to decreased adherence to treatment and ultimately diminish the effectiveness of IOP control. The study aimed to determine the efficacy and tolerability of BAK-free travoprost preserved with polyquaternium-1 in glaucoma patients switched from BAK-preserved latanoprost or bimatoprost.
Methods: This 12-week, open-label study was conducted in Europe between December 2011 and February 2013. We enrolled adult patients with open-angle glaucoma or ocular hypertension who were receiving BAK-preserved latanoprost 0.005% or bimatoprost 0.01% and, in the opinion of the investigator, would benefit from transition to BAK-free travoprost 0.004% preserved with polyquaternium-1 because of tolerability concerns. Assessments included IOP, proportion of patients with IOP ≤18 mmHg, ocular surface status, hyperemia, patient treatment preference, and adherence. Adverse events were recorded throughout the study.
Results: Of the 202 patients screened, 187 patients were included in the intent-to-treat population (mean age, 66.6 years; range, 19–90 years). The mean IOP significantly reduced from baseline (17.0 mmHg) to week 6 (mean change, -1.17 mmHg; P<0.001) and week 12 (-1.16 mmHg; P<0.001). At week 12, more patients achieved IOP ≤18 mmHg (81.2% versus 73.3% at baseline), and ocular surface disease severity improved from baseline to week 12. Most patients preferred BAK-free travoprost (74.9%) versus their previous medication and were very confident in their adherence (84.1%). Reduced visual acuity and eye pruritus were the most common adverse events (2.5% each).
Conclusion: BAK-free travoprost 0.004% preserved with polyquaternium-1 was efficacious and well tolerated and may be an advantageous prostaglandin analog option for patients with open-angle glaucoma or ocular hypertension who are intolerant to BAK-preserved latanoprost or bimatoprost.

Keywords: benzalkonium chloride, intraocular pressure, polyquad, polyquaternium-1, prostaglandin analog, switch, travoprost