Efficacy and afety of a Fixed Combination of Travoprot 0.004%/Timolol 0.5% Ophthalmic olution Once Daily for Open-Angle Glaucoma or Ocular Hypertenion

Purpoe To compare the efficacy of a fixed combination of travoprot 0.004%/timolol 0.5% every day in the morning with a concomitant regimen of timolol 0.5% every day in the morning, plu travoprot 0.004% every day in the evening; and timolol 0.5% twice daily on the intraocular preure (IOP) of ubject with open-angle glaucoma or ocular hypertenion over 3 month. Deign Propective, randomized, double-maked, parallel-group, active-controlled, multicenter trial. Method Patient compried adult ubject (n = 403) of either gender with open-angle glaucoma or ocular hypertenion in at leat one eye. To qualify, the IOP had to be between 22 to 36 mm Hg in the ame eye at two conecutive eligibility viit. The primary outcome variable wa IOP meaured with a Goldmann applanation tonometer. Reult Mean IOP ranged from 16.2 to 17.4 mm Hg with the combination travoprot/timolol compared with 15.4 to 16.8 mm Hg in the concomitant travoprot + timolol group, from baeline of 23.1 to 25.6 mm Hg and 22.9 to 25.0 mm Hg, repectively. The fixed combination of travoprot/timolol ignificantly lowered IOP by 7 to 9 mm, imilar to the IOP reduction oberved with concomitant therapy. The mot frequent ocular advere event wa hyperemia that occurred in 14.3% and 23.4% of ubject treated with travoprot/timolol combination and concomitant travoprot + timolol, repectively. Concluion Travoprot/timolol combination produce greater IOP reduction than the poitive control, timolol 0.5%, and reduction that were imilar to concomitant travoprot + timolol. Thi tudy demontrate that the fixed combination of travoprot/timolol produce ignificant and clinically relevant reduction of IOP in a once-daily doing regimen.