Comparison of preservative‐free latanoprost and bimatoprost in a multicenter, randomized, investigator‐masked cross‐over clinical trial

Abstract

PurposeTo investigate the efficacy and safety of Bimatoprost Unit Dose Preservative Free (BUDPF) and Latanoprost Unit Dose Preservative Free (LUDPF) in a clinical setting.MethodsProspective, 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.ResultsBoth 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).ConclusionsThis study demonstrate a superior efficacy of BUDPF over LUDPF in lowering IOP.