Randomized crossover trial comparing effectiveness and tolerability of generic and brand-name travoprost

Abstract

Objective: The primary goal is to determine if the intraocular pressure reducing effect of generic Sandoz travoprost is equivalent to that of brand-name Travatan Z. The secondary goal is to determine if generic Sandoz travoprost is as well tolerated as Travatan Z.

Methods: This prospective randomized crossover trial allocated 76 patients with primary open-angle glaucoma, normotensive glaucoma, or ocular hypertension in a 1:1 ratio to start with either generic Sandoz travoprost or Travatan Z. Crossover happened after 3 weeks. The primary endpoint, intraocular pressure, was measured in both eyes at baseline, at week 3, and at week 6. The secondary endpoint was tolerability of both drugs as assessed by a questionnaire administered at week 3 and week 6.

Results: The intraocular pressure lowering effect of generic Sandoz travoprost was equivalent to that of Travatan Z (18.20 ± 3.41 mmHg and 18.44 ± 3.48 mmHg respectively, p < 0.0001). Tolerability, as measured with a questionnaire, was similar between the two formulations of travoprost.

Conclusion: This study is the first to compare a brand-name travoprost with one of its generic forms and adds to the body of evidence that generic glaucoma eye drops are as effective and well-tolerated as their brand name counterparts. The intraocular pressure lowering effect of generic Sandoz travoprost is equivalent to that of Travatan Z. Patient tolerance of generic and brand-name travoprost is similar.