COMPARISON OF THE SAFETY AND EFFICACY OF THE FIXED COMBINATION OF DORZOLAMIDE TIMOLOL AND THE CONCOMITANT ADMINISTRATION OF DORZOLAMIDE ANDTIMOLOL - A CLINICAL EQUIVALENCE STUDY/

Aims-To compare the tolerability and efficacy of a fixed combination s olution of dorzolamide/timolol (Cosopt), administered twice daily with the concomitant administration of its components, dorzolamide (Trusop t) twice daily and timolol (Timoptic) twice daily. Methods-After a 2 w eek timolol run in, patients with open angle glaucoma or ocular hypert ension were randomised (1:1) to receive treatment with either the dorz olamide/timolol combination solution twice daily (combination) or the dorzolamide solution twice daily plus timolol maleate solution twice d aily (concomitant) for 3 months. Results-299 patients were entered and 290 patients completed the study. Compared with the timolol baseline, additional IOP lowering of 16% was observed at trough (hour 0) and 22 % at peak (hour 2) at month 3 in both the concomitant and combination groups. The IOP lowering effects of the two treatment groups were clin ically and statistically equivalent as demonstrated by the extremely s mall point differences (concomitant - combination) observed in this st udy-0.01 mm Hg at trough and 0.08 mm Hg at peak. The safety variables of the concomitant and combination groups were very similar. Both comb ination and concomitant therapy were well tolerated and few patients d iscontinued due to adverse effects.Conclusions-The dorzolamide/timolol combination solution administered twice daily is equivalent in effica cy and has a similar safety profile to the concomitant administration of the components administered twice daily.