Abstract
Purpose: :
To evaluate the efficacy of fixed combination brimonidine–timolol (Combigan®) versus fixed combination dorzolamide–timolol (Cosopt®) given twice daily in primary open angle glaucoma or ocular hypertension subjects.
Methods: :
In this prospective, multicenter, masked–observer, crossover comparison 30 subjects were washed out from their previous medication and randomized to Combigan® or Cosopt® for the first 4–week treatment period. Subjects then were washed for 4 weeks and started on the opposite medication for the second 4–week period. Intraocular pressure (IOP) was measured at 8:00 am, 12:00 pm, and 4:00 pm at each baseline and at the end of each treatment period. Unsolicited ocular adverse events were also recorded.
Results: :
The baseline mean diurnal IOP for all 30 subjects (30 eyes) was 22.9 ± 1.6 mmHg. Both fixed combinations significantly reduced IOP compared with baseline (p<0.00001). The mean diurnal IOP following 4 weeks of therapy was 15.0 ± 2.1 mmHg for Combigan® and 15.4 ± 2.1 mmHg for Cosopt® (p=0.5097). The mean percentage reduction in diurnal IOP was 34.3 ± 8.5% for Combigan® and 32.9 ± 8.6% for Cosopt® (p=0.5456). Overall, 14 subjects complained about ocular adverse events: 2 only for Combigan®, 7 only for Cosopt® and 5 for both drugs. Although there was no significant difference between the number of subjects that reported ocular adverse events with Combigan® (n=7) and Cosopt® (n=12) (p=0.2669), Cosopt® caused more ocular stinging upon instillation (n=9) than Combigan® (n=1) (p=0.0198).
Conclusions: :
This study suggests that Combigan® and Cosopt®, each given twice daily, have similar efficacy in primary open angle glaucoma or ocular hypertensive subjects.
Keywords: clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • pharmacology • intraocular pressure