Abstract
Purpose::
A prospective randomized controlled trial comparing fixed combination timolol 0.5%/dorzolamide 2% with timolol 0.5%/brimonidine 0.2% to determine which combination preparation provides superior intraocular pressure (IOP) control and a better side-effect profile.
Methods::
Patients with any type of glaucoma using timolol/dorzolamide were identified from the Moorfields Eye Hospital pharmacy database and review of clinic notes. Those with stable IOP of ≤22mmHg using timolol/dorzolamide alone or with other medications were invited to take part in a prospective, randomized trial and allocated timolol/dorzolamide or timolol/brimonidine in a double masked fashion. Randomization was by patient according to a computer generated list held by the dispensing pharmacist. Where both eyes were eligible the right eye was selected for analysis. Primary variable was IOP measured at baseline, four weeks and 12 weeks. Secondary variables included side-effects and patient preference.
Results::
1400 patients were screened of whom 825 were eligible for enrolment. 54 patients have completed the trial; 42 were male, mean age [range] was 69 years [26-87]. Of the 26 eyes randomized to timolol/dorzolamide mean IOP was 15.2mmHg [9-20] at baseline, 15.5 mmHg [12-21] at four weeks and 17.8mmHg [14-22] at twelve weeks. Of 28 eyes randomized to timolol/brimonidine mean IOP was 15.5mmHg [11-22] at baseline, 15.0mmHg [10-19] at four weeks and 15.7mmHg [12-23] at twelve weeks. Three patients developed a "red eye", exited the trial and were unmasked. Two were using timolol/dorzolamide and one timolol/brimonidine.
Conclusions::
Both fixed combinations had a comparable effect on IOP and a low incidence of side-effects.
Clinical Trial::
EudraCT (European Community Trials Database)
Keywords: clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • intraocular pressure • drug toxicity/drug effects