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Equivalent IOP lowering found when travoprost is preserved with polyquaternium or benzalkonium chloride
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Researchers found no significant differences between the intraocular pressure-lowering efficacy of polyquaternium-1-preserved travoprost and benzalkonium chloride-preserved travoprost when treating patients with open-angle glaucoma or ocular hypertension.
“The IOP-lowering efficacy of polyquaternium-1–preserved travoprost 0.003% was equivalent to that of benzalkonium chloride–preserved travoprost 0.004% in this population of patients with open-angle glaucoma or ocular hypertension,” James H. Peace, MD, and colleagues wrote in their study. “The safety profiles of the travoprost 0.003% and travoprost 0.004% solutions were similar.”
Peace and colleagues conducted a multicenter clinical trial of 864 patients recruited from 60 centers in the U.S. and Europe between November 2011 and August 2012. Each patient was randomized to receive daily doses of either polyquaternium-1–preserved travoprost 0.003% or benzalkonium chloride–preserved travoprost 0.004% over a 3-month period. The researchers assessed patients’ IOP at three time periods: 2-week follow-up, 6-week follow-up and 3-month follow-up, according to the study. They found no significant difference among mean IOP for patients in any group at all follow-up periods.
Peace and colleagues also found the mean percentage reductions in IOP for each group were similar from 2-week follow-up to 3-month follow-up (travoprost 0.003%, 28.4% to 30.7%; travoprost 0.004%, 28.5% to 31.0%). They noted that throughout the study and follow-up periods the percentages of patients who had an IOP of less than 18 mm Hg and at least 30% reduction of IOP were similar.
The authors added that a limitation of this study was that travoprost 0.003% was not compared with currently marketed travoprost formulations preserved with sofZia or
polyquaternium-1 or with other marketed prostaglandin analogs.
“Comparison of polyquaternium-1–preserved travoprost 0.003% and polyquaternium-1–preserved travoprost 0.004% would enable direct assessment of the effect of travoprost concentration on hyperemia rates and adverse event profiles,” they said. – by Jeffrey Craven
Disclosure: Ahlberg is on the speakers bureau for Puls & Ackordbyrån and is a consultant for Alcon. Wirta has received grant support from Alcon.
Perspective
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Blair Lonsberry, OD, FAAO
As a result of their efficacy and safety profile, prostaglandin analogs are considered first-line therapy for most glaucoma patients. Patient adherence is influenced by multiple factors, including the development of hyperemia and other ocular side effects. This clinical trial was designed to demonstrate equivalence between travoprost 0.003% solution and the currently available travoprost 0.004% in adult patients with open-angle glaucoma or ocular hypertension. The authors wanted to determine if a lower concentration of travoprost and a non-BAK preserved formulation would show equivalent IOP lowering with lower side effects.
Travoprost 0.003% and travoprost 0.004% produced similar IOP reductions through 3 months of treatment, and the criterion for equivalence was met. Treatment-related hyperemia was observed in 12% of patients receiving travoprost 0.003% and in 15% of those receiving travoprost 0.004%. More patients in the travoprost 0.004% group had an increase in hyperemia score greater than 1 unit during treatment.
This study demonstrates a potential avenue to somewhat reduce hyperemia in patients taking travoprost by reducing the drug concentration and utilizing a non-BAK formulation. A limitation to this current study is that the commercially available travoprost in the U.S./Canada is preserved with sofZia, which was not evaluated in this study.
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