Efficacy and safety of travoprost/timolol vs dorzolamide/timolol in patients with open-angle glaucoma or ocular hypertension

Miguel A Teus¹, Stefano Miglior², Guna Laganovska³, Lasma Volksone⁴, Bozena Romanowska-Dixon⁵, Roman Gos⁶, Gábor Holló⁷, for the C-05-25 Study Group⁸

¹Hospital Príncipe de Astúrias, Universidad de Alcalá, Madrid, Spain; ²Clinica Oculistica, Policlinico di Monza Università di Milano Bicocca, Monza (MI), Italy; ³Department of Ophthalmology, Stradina Clinical University Hospital, Riga, Latvia; ⁴Glaucoma Service, Clinical Hospital Gailezera, Riga, Latvia; ⁵Szpital Uniwersytecki w Krakowie, Kraków, Poland; ⁶Contact-Med, Sp. z o.o., Łódź, Poland; ⁷Semmelweis University, Department of Ophthalmology, Budapest, Hungary; ⁸The C-05-25 Study Group: Members are listed under Acknowledgments

Purpose: To compare the intraocular pressure- (IOP-) lowering efficacy of fixed combinations travoprost 0.004%/timolol 0.5% and dorzolamide 2%/timolol 0.5% in patients with ocular hypertension or open-angle glaucoma.

Methods: In this prospective, multicenter, double-masked, randomized clinical trial, 319 qualifying patients received either travoprost/timolol once daily in the morning (n = 157) or dorzolamide/timolol twice daily (n = 162). IOP was assessed morning and evening at 2 and 6 weeks. The primary outcome measure was mean diurnal IOP.

Results: Baseline mean IOP values were similar between groups. Mean pooled diurnal IOP was significantly lower in the travoprost/timolol group (16.5 mmHg ± 0.23) than in the dorzolamide/timolol group (17.3 mmHg ± 0.23; P = 0.011). Mean IOP was significantly lower in the travoprost/timolol group compared to the dorzolamide/timolol group at the 9 AM time point both at Week 2 (P = 0.006) and Week 6 (P = 0.002). The travoprost/timolol combination produced mean IOP reductions from baseline of 35.3% to 38.5%, while the dorzolamide/timolol combination produced mean IOP reductions from baseline of 32.5% to 34.5%. Conclusions: The fixed combination travoprost 0.004%/timolol 0.5% dosed once daily in the morning demonstrated superior mean diurnal IOP-lowering efficacy compared to dorzolamide 2%/timolol 0.5% dosed twice daily in patients with ocular hypertension or open-angle glaucoma.

Keywords: dorzolamide, fixed combination, glaucoma, IOP-lowering therapy, timolol, travoprost