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Войти в исследования European journal of ophthalmology · 2009
A 12-week study evaluating the efficacy of bimatoprost 0.03% in patients with pseudoexfoliative and open-angle glaucoma.
Сравнительное исследованиеКонтролируемое клиническое исследованиеСтатьяНазвание и аннотация: Перевод пока не подготовлен
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Ciancaglini Marco, Carpineto Paolo, Agnifili Luca, Nubile Mario, Toto Lisa, Mastropasqua Leonardo
Аннотация
PURPOSE: To evaluate the control of diurnal intraocular pressure (IOP) and the safety profile of bimatoprost in pseudoexfoliative glaucoma (PXG) compared to primary open angle glaucoma (POAG).
METHODS: A prospective, observer-masked, nonrandomized study was performed. Seventy consecutive patients with either POAG (35 eyes) or PXG (35 eyes) drug-naive for glaucoma were assigned to receive bimatoprost 0.03% once daily for 12 weeks. Diurnal IOP was measured at baseline and after 12 weeks at three time points (8 AM, noon, and 4 PM). Main outcomes were diurnal IOP control and achievement of target IOP (CIGTS criteria). Mean diurnal IOP, hour-by-hour IOP measurements, and safety, including serious adverse events, were also evaluated.
RESULTS: A significant IOP reduction from baseline was found in both groups (p<0.001). Mean and hour-by-hour IOP differences between groups were not statistically significant (NS). The observed IOP values and percentages of IOP reduction were 17.0 mmHg (31.5%) and 16.4 mmHg (31.9%) in PXG and POAG eyes, respectively; the differences were not statistically significant. Six eyes (1 POAG and 5 PXG, respectively) responded with a <20% IOP reduction (NS). Twenty-seven POAG (77.1%) and 23 PXG (65.7%) eyes achieved target IOP. Consequently,20 eyes (8 POAG and 12 PXG, respectively) were classified as unable to achieve the IOP target values (NS).
CONCLUSIONS: Bimatoprost was effective and safe in lowering IOP both in open angle and pseudoexfoliative glaucoma, achieving target pressure in most patients. However, long-term efficacy in PXG must be evaluated.
METHODS: A prospective, observer-masked, nonrandomized study was performed. Seventy consecutive patients with either POAG (35 eyes) or PXG (35 eyes) drug-naive for glaucoma were assigned to receive bimatoprost 0.03% once daily for 12 weeks. Diurnal IOP was measured at baseline and after 12 weeks at three time points (8 AM, noon, and 4 PM). Main outcomes were diurnal IOP control and achievement of target IOP (CIGTS criteria). Mean diurnal IOP, hour-by-hour IOP measurements, and safety, including serious adverse events, were also evaluated.
RESULTS: A significant IOP reduction from baseline was found in both groups (p<0.001). Mean and hour-by-hour IOP differences between groups were not statistically significant (NS). The observed IOP values and percentages of IOP reduction were 17.0 mmHg (31.5%) and 16.4 mmHg (31.9%) in PXG and POAG eyes, respectively; the differences were not statistically significant. Six eyes (1 POAG and 5 PXG, respectively) responded with a <20% IOP reduction (NS). Twenty-seven POAG (77.1%) and 23 PXG (65.7%) eyes achieved target IOP. Consequently,20 eyes (8 POAG and 12 PXG, respectively) were classified as unable to achieve the IOP target values (NS).
CONCLUSIONS: Bimatoprost was effective and safe in lowering IOP both in open angle and pseudoexfoliative glaucoma, achieving target pressure in most patients. However, long-term efficacy in PXG must be evaluated.