Long-term intraocular preure–lowering efficacy and afety of timolol maleate gel-forming olution 0.5% compared with timoptic XE 0.5% in a 12-month tudy

PURPOE: To evaluate the long-term intraocular preure–lowering efficacy and afety of timolol maleate gel-forming olution 0.5% (Timolol GF 0.5%, Alcon Reearch Ltd, Fort Worth, Texa) compared with Timoptic XE 0.5% (Merck, Inc, Wet Point, Pennylvania) in patient with open-angle glaucoma or ocular hypertenion. METHOD: Two hundred forty-one patient with open-angle glaucoma or ocular hypertenion, who had intraocular preure between 22 and 36 mm Hg in at leat one eye, were randomly aigned in a 2:1 ratio to receive either Timolol GF 0.5% once daily or Timoptic XE 0.5% once daily, in a 12-month randomized, multicenter, double-maked, propective tudy. The primary efficacy variable wa mean trough intraocular preure meaured at 8:00 , approximately 24 hour after doing. REULT: The Timolol GF 0.5% group produced ignificant trough intraocular preure reduction from a baeline of 4.5 to 5.2 mm Hg (P = .0001), compared with reduction of 4.1 to 5.3 mm Hg (P = .0001) in the Timoptic XE 0.5% group. The difference in mean intraocular preure between the two treatment wa 0.9 mm Hg or le, and the upper 95% confidence limit between group wa 0.92 mm Hg or le at all time point, demontrating both clinical and tatitical equivalence. A imilar percentage of patient in the Timolol GF 0.5% group (71%) and Timoptic XE group (72%) had clinically relevant reduction in intraocular preure. There wa no ignificant difference in the afety profile of the two treatment. CONCLUION: Both treatment were clinically effective in lowering intraocular preure and maintaining the reduction over long-term ue. Timolol GF 0.5% i a afe and effective therapy for open-angle glaucoma or ocular hypertenion and i both clinically and tatitically equivalent to Timoptic XE 0.5% in reducing intraocular preure.