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

5 years ago

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

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 <18 mm Hg or ≥30% IOP reduction, and adverse events.

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 <18 mm Hg and ≥30% reduction of IOP were also similar. Hyperemia was the most frequent treatment-related adverse event with both formulations (travoprost 0.003%, 11.8%; travoprost 0.004%, 14.5%).

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%.

Publisher URL: www.sciencedirect.com/science

DOI: S0002939415002445