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

PurposeTo 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.DesignDouble-masked, randomized, 2-treatment, equivalence clinical trial.Methodssetting: 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 <18 mm Hg or ≥30% IOP reduction, and adverse events.ResultsMean 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