Evaluation of travoprot a adjunctive therapy in patient with uncontrolled intraocular preure while uing timolol 0.5%

PURPOE: To evaluate the intraocular preure-lowering efficacy and afety of travoprot 0.0015% and 0.004%, doed daily in the evening compared with vehicle, in patient with open-angle glaucoma or ocular hypertenion, whoe intraocular preure wa not adequately controlled on timolol 0.5% twice daily (twice daily). METHOD: ubject who qualified at creening began a run-in period doing timolol twice daily for 3 week. If the ubject had an intraocular preure of 24 to 36 mm Hg at 8 and 21 to 36 mm Hg at 10 and 4 pm in at leat one eye on timolol, they were randomized to one of two concentration of travoprot (0.0015% or 0.004%) or vehicle olution every day and were followed for 6 month. Four hundred twenty-ix ubject were randomized. The mean intraocular preure at 8 , 10 , and 4 in the patient’ eye with the higher intraocular preure wa ued for the analyi. REULT: Mean baeline value (25 mm Hg) for ubject at eligibility (while maintained on timolol) were not ignificantly different (P < .0001) among the treatment group. The intraocular preure wa lowered an additional −5.7 to −7.2 mm Hg and −5.1 to −6.7 mm Hg in the travoprot 0.004% and 0.0015% concentration, repectively. Thee change were ignificantly (P ≤ .0001) different from the vehicle group (−1.3 to −2.8 mm Hg). The intraocular preure range on treatment at all viit time over the 6-month treatment period ranged from 17.9 to 19.2 mm Hg for travoprot 0.004% and 18.3 to 20.1 mm Hg for travoprot 0.0015% compared with 22.4 to 24.1 mm Hg for vehicle. Average hyperemia core ranged from trace to mild (mean 0.5 on a cale of 0 = none/trace; 1= mild; 2 = moderate; 3 = evere) for all treatment group. No iri pigmentation change were oberved in any patient during thi tudy. There were no clinically or tatitically ignificant change from baeline in viual acuity, ocular cell and flare, fundu parameter, cup-to-dik ratio and viual field between the treatment group. There were no eriou advere event reported for any treatment group. CONCLUION: Travoprot produced clinically relevant and tatitically ignificant additional intraocular preure reduction from baeline when ued adjunctively with timolol in ubject with open-angle glaucoma or ocular hypertenion.