Comparison of the Efficacy and Tolerability of Xalatan® and Xalabiost (Generic Latanoprost) in Adults with Open-Angle Glaucoma or Ocular Hypertension: A Two-Center, Randomized, Crossover Trial

Purpose : To compare the intraocular pressure (IOP) lowering effect and side effects of Xalatan with generic Latanoprost (Xalabiost) in adults with open-angle glaucoma or ocular hypertensionMethods : This was a two-center prospective randomized, crossover clinical trial. Eligible patients with open-angle glaucoma or ocular hypertension were sequentially randomized to two parallel study groups receiving Xalatan and Xalabiost in two periods. The primary efficacy outcome was change in the mean of IOP between baseline and end of each treatment period, and secondary outcomes included differences between treatment groups in mean percent change in IOP from baseline and in proportions of patients reaching specified target mean IOP levels.Results : Nineteen patients in BX group (receiving Xalabiost in first and passing to Xalatan in second treatment period) and 22 patients in XB group (receiving Xalatan in first period and Xalabiost in second treatment period) completed both treatment periods. The mean baseline IOP was 24.9 mmHg in group XB and 25.4 mmHg in group BX (P=0.57). At the end of Xalatan treatment periods, patients experienced a 7.5±1.3 mmHg (29.8±3.6 percent) reduction in IOP compared to baseline IOP. Xalabiost treated patients had a 7.3±1.2 mmHg (29.2±3.3 percent) decrease in IOP compared to baseline IOP (P=0.084). Adverse ocular events were mild in both treatment groups.Conclusion : Both Xalatan and generic Latanoprost (Xalabiost) reduced IOP effectively after 1 month of treatment in patients with primary open-angle glaucoma or ocular hypertension, with no significant difference in efficacy and tolerability between them