Efficacy and tolerability of benzalkonium chloride-free travoprost in glaucoma patients switched from benzalkonium chloride-preserved latanoprost or bimatoprost
Authors García-Feijoo J, Muñoz-Negrete FJ, Hubatsch DA, Rossi GC
Received 13 May 2016
Accepted for publication 26 July 2016
Published 21 October 2016 Volume 2016:10 Pages 2085—2091
Checked for plagiarism Yes
Review by Single-blind
Peer reviewers approved by Dr Colin Mak
Peer reviewer comments 3
Editor who approved publication: Dr Scott Fraser
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
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