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L. Katz, R. Lewis, A. Batoosingh, C.-C. Liu; Bimatoprost/timolol Fixed Combination: A One-Year Double-Masked, Randomized Parallel Comparison to Its Individual Components in Patients With Glaucoma or Ocular Hypertension. Invest. Ophthalmol. Vis. Sci. 2007;48(13):5561.
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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.
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.
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).
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.
www.clinicaltrials.gov NCT00332540 and NCT00332072
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