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Comparison of preservative‐free latanoprost and bimatoprost in a multicenter, randomized, investigator‐masked cross‐over clinical trial
Author(s) -
Stalmans I.,
Cordeiro F.,
Hommer A.,
Oddone F.,
Ribeiro L.,
Sunaric Mégevand G.,
Rossetti L.
Publication year - 2015
Publication title -
acta ophthalmologica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.534
H-Index - 87
eISSN - 1755-3768
pISSN - 1755-375X
DOI - 10.1111/j.1755-3768.2015.1360
Subject(s) - bimatoprost , latanoprost , medicine , tolerability , randomized controlled trial , glaucoma , ophthalmology , clinical endpoint , clinical trial , ocular hypertension , adverse effect
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 ≤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 .