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

Aim: To compare the efficacy and tolerability of Xalatan ® with generic latanoprost (Latoprost) in subjects with primary open angle glaucoma (POAG) or ocular hypertension (OH). Materials and Methods: 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. Results: 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. Conclusion: 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.

Keywords

• Intraocular pressure
• Latoprost
• ocular hypertension
• primary open angle glaucoma
• Xalatan &#x00AE;