A randomized, crossover, open label pilot study to evaluate the efficacy and safety of Xalatan ® in comparison with generic Latanoprost (Latoprost) in subjects with primary open angle glaucoma or ocular hypertension

Abstract

To compare the efficacy and tolerability of Xalatan with generic latanoprost (Latoprost) in subjects with primary open angle glaucoma (POAG) or ocular hypertension (OH). This was a single-center, randomized, open label, crossover, two period comparative study. At the baseline visit, subjects were randomized to two groups. Group A received Xalatan for weeks 1-12 followed by Latoprost for weeks 13-24. Group B received Latoprost for weeks 1-12 followed by Xalatan for weeks 13-24. 30 subjects were recruited, 12 in Group A and 18 in Group B. In subjects administered Xalatan, intraocular pressure (IOP) showed a greater decrease (P < 0.001) from 23.64 +/- 3.13 mmHg at baseline to 14.29 +/- 1.61 mmHg at week 12 (fall of 9.35 +/- 3.55 mmHg, 38.66% +/- 10.29) than that seen in the Latoprost group (22.74 +/- 2.47 mmHg to 16.98 +/- 2.49 mmHg, fall of 5.76 +/- 1.41 mmHg; 25.42% +/- 5.98). In period 2 when subjects were crossed over to Xalatan from Latoprost, there was a further fall from 16.98 +/- 2.49 mmHg to 16.09 +/- 1.49 at week 24 (fall of 0.89 +/- 1.59 mmHg; 4.3% +/- 8.76). However, when subjects were crossed over to Latoprost from Xalatan, the IOP rose from 14.29 +/- 1.61 mmHg to 15.36 +/- 1.71 mmHg at week 24 (8.86% +/- 17.76). There was no significant difference in incidence of conjunctival hyperemia or any other adverse events in both the groups. The magnitude of IOP lowering in patients with POAG and OH with Xalatan and Latoprost is different. In our study, the IOP lowering with Xalatan was higher than that with Latoprost.