Purpose:
To compare the 12–hour efficacy and safety of the dorzolamide/timolol fixed combination dosed twice daily versus latanoprost dosed every evening following a timolol maleate run–in in patients with primary open–angle glaucoma or ocular hypertension.
Methods:
A prospective, double–masked, active–controlled, two–period, crossover comparison in which patients, following a six–week timolol maleate run–in, were randomized to either the dorzolamide/timolol fixed combination or latanoprost for six weeks for Period 1 and then crossed over to the opposite treatment for six weeks in Period 2. At the end of the run–in period, as well as at the end of each treatment period, patients underwent diurnal curve testing with Goldmann applanation tonometry every two hours between 08:00 and 20:00 hours.
Results:
Thirty patients completed at least one time point in both treatment periods. The intraocular pressure results are shown in the table. Intraocular pressure results (mm Hg)
DTFC= dorzolamide/timolol maleate fixed combination
There was no statistical difference for the 12–hour diurnal average of the intraocular pressure between treatments or at any individual time point (P < 0.05). Regarding adverse events, there were seven reported side effects on latanoprost and 16 on the dorzolamide/timolol fixed combination. There was no statistical difference for any individual adverse event between treatments.
Conclusions:
This study suggests that, following a timolol maleate run–in, both the dorzolamide/timolol fixed combination and latanoprost provide comparable daytime diurnal efficacy and safety.
Keywords: clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • intraocular pressure