Abstract
Purpose::
To evaluate the safety and efficacy of a fixed combination of bimatoprost and timolol (GAN) compared to each of the active components for one year.
Methods::
Two double-masked, randomized, multi-center parallel studies of GAN (q.d., mornings), bimatoprost (q.d., evenings, BIM), or timolol (b.i.d., TIM) were conducted in 1061 patients with glaucoma or ocular hypertension.
Results::
Overall, 87.0% (923/1061) of patients completed the one-year treatment period, and discontinuation rates were similar in all three treatment groups: 12.2% (65/533) of GAN, 15.1% (40/265) of BIM, and 12.5% (33/263) of TIM patients. The proportion of patients with a mean diurnal percent change from baseline in IOP of more than 20% across all visits was 68.1% (363/533), 58.1% (154/265) and 38.0% (100/263) for the GAN, BIM and TIM groups, respectively (p < 0.003 for GAN vs. BIM and p < 0.001 GAN vs. TIM). The proportion of patients achieving a mean diurnal IOP of less than 18 mm Hg at all visits was met 43.5% (232/533), 35.8% (95/265), and 18.6% (49/263) for the GAN, BIM and TIM groups, respectively (p =0.021 for GAN vs. BIM, and p < 0.001 for GAN vs. TIM). The most commonly reported treatment-related adverse event was conjunctival hyperemia, with an incidence of 25.7% (137/533) in GAN, 43.4% (115/265) in BIM and 8.7% (23/263) in TIM (p < 0.001 for GAN vs. BIM and GAN vs. TIM).
Conclusions::
GAN was clinically and statistically significantly more effective than BIM or TIM, and better tolerated, and safer than BIM with respect to common ocular adverse events. GAN, a single-bottle, fixed combination represents a convenient, therapeutic advantage over separate bottles.
Clinical Trial::
www.clinicaltrials.gov NCT00332540 and NCT00332072
Keywords: clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials