Comparison of preservative-free latanoprost and bimatoprost in a multicenter, randomized, investigator-masked cross-over clinical trial
Abstract
Purpose
To investigate the efficacy and safety of Bimatoprost Unit Dose Preservative Free (BUDPF) and Latanoprost Unit Dose Preservative Free (LUDPF) in a clinical setting.
Methods
Prospective, randomized, investigator-masked, cross-over comparison. Patients with ocular hypertension or open angle glaucoma (OAG) with an IOP less than or equal to 21 mmHg with a preserved prostaglandin monotherapy at screening were washed out and randomized to receive BUDPF or LUDPF for 3 months and were then switched to the other respective treatment for another 3 months. IOP curves were performed at baseline and after each treatment period, and safety and tolerability were assessed at the two latter timepoints.
Results
Both drugs were effective in lowering IOP, both at 3 and at 6 months (estimated differences compared to baseline pressures: −4.0 ± 0.5 for both BUDPF and LUDPF, p < 0.01 at 3 months; −5.2 ± 0.5 for BUDPF, −3.4 ± 0.5 for LUDPF, both p < 0.01 at 6 months). Analysis at 6 months (primary endpoint) showed a difference of 1.6 ± 0.5 mmHg between the two groups, favoring BUDPF (p < 0.01). An intra-subject IOP difference of 0.9 ± 0.2 mmHg in favor of BUDPF was observed (p < 0.01).
Conclusions
This study demonstrate a superior efficacy of BUDPF over LUDPF in lowering IOP.
