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Gabor Hollo, Anton Hommer, Alfonso Anton, Auli Ropo; Preservative-free tafluprost 0.0015%/timolol 0.5% fixed dose combination: a 6-month double-masked, randomized multicenter P-III comparison to concomitant use of the individual preservative-free components in patients with glaucoma or ocular hypertension. Invest. Ophthalmol. Vis. Sci. 2013;54(15):446.
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To evaluate the efficacy, tolerability and safety of preservative-free fixed dose combination (FDC) of tafluprost 0.0015% and timolol 0.5% once daily compared to the concomitant use of preservative-free tafluprost 0.0015% once daily and preservative-free timolol 0.5% twice daily (non-fixed combination, NFC).
This study was a 6-month double-masked randomised, multicenter parallel group investigation (clinicaltrial.gov No: NCT 01306461). After washout patients were randomised to either, preservative-free FDC tafluprost-timolol (once-daily) and placebo (twice daily) (n=201) or NFC of tafluprost (once-daily) and timolol (twice-daily) (n=199). Study visits included screening, baseline, 2, 6 weeks, 3 and 6 months. IOP was measured at 8 a.m., 10 a.m. and 4 p.m. during each visit. Primary efficacy variable was the change from average diurnal baseline IOP at month 6, secondary efficacy variable was the proportion of responders at month 6.
A substantial and comparable IOP reduction from mean baseline IOP of 25.11 mmHg (identical for FDC and NFC) was seen in both groups. Mean IOP decrease from baseline for all IOP measurements was -9.13 to -7.30 mmHg in the FDC and -9.43 to -7.54 mmHg in the NFC group (PP analysis, p<0.0001 for both groups). At 6 months, the estimated overall treatment difference (FDC - NFC) in the PP analysis was 0.308 mmHg with a 95% CI from -0.194 to 0.810 mmHg (p=0.228). The upper limit of the CI was clearly below the pre-specified margin of 1.5 mmHg providing strong evidence on the non-inferiority between FDC and NFC. An IOP lowering effect of >30% from baseline was achieved at month 6 in 58.3% and 66.9% of patients treated with FDC and NFC respectively. Patients with related ocular AEs were evenly distributed between FDC and NFC groups (21.4% and 18.6%). Hyperaemia was reported in 16 patients (8.0%) in the FDC group and in 10 patients (5.0%) in the NFC group, and was generally of mild or moderate severity.
A substantial and comparable IOP reduction was seen both for FDC and NFC throughout the 6-month study period. Both, primary and secondary efficacy variables unanimously evidenced non-inferiority between the two treatment arms in reduction of IOP.
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