Polyquaternium-1–Preserved Travoprost 0.003% or Benzalkonium Chloride–Preserved Travoprost 0.004% for Glaucoma and Ocular Hypertension

Purpose To demonstrate equivalence of polyquaternium-1–preserved travoprost 0.003% with benzalkonium chloride–preserved travoprost 0.004% in patients with open-angle glaucoma or ocular hypertension. Design Double-masked, randomized, 2-treatment, equivalence clinical trial. Methods setting: Multicenter clinical trial conducted in 60 centers in the United States and Europe. patient population: Adult patients with open-angle glaucoma or ocular hypertension. One eye per patient was analyzed. intervention: Patients were randomized 1:1 to receive polyquaternium-1–preserved travoprost 0.003% (n = 442) or benzalkonium chloride–preserved travoprost 0.004% (n = 422) once daily for 3 months. main outcome measures: Mean intraocular pressure (IOP) was assessed at 8 AM, 10 AM, and 4 PM at week 2, week 6, and month 3. Supportive outcomes were mean and percent IOP change, percentage of patients achieving IOP Results Mean IOP was similar between groups at all study visits (travoprost 0.003% range, 17.5–18.9 mm Hg; travoprost 0.004% range, 17.4–19.0 mm Hg). Mean change (least squares mean differences, −0.1 to 0.3 mm Hg; 95% confidence interval, −0.5 to 0.7 mm Hg) and percentage change (travoprost 0.003%, 28.4%–30.7%; travoprost 0.004%, 28.5%–31.0%) from baseline were comparable. The percentages of patients with IOP Conclusions In patients with open-angle glaucoma or ocular hypertension, polyquaternium-1–preserved travoprost 0.003% solution provided equivalent IOP-lowering efficacy to that of benzalkonium chloride–preserved travoprost 0.004%.