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L.–I. Larsson, M. Diestelhorst, European–Canadian Latanoprost Fixed Combination Study Group; A 12–Week, Randomized, Double–Masked Multicenter Study of the Fixed Combination Latanoprost and Timolol in the Evening vs. the Individual Components . Invest. Ophthalmol. Vis. Sci. 2005;46(13):2459.
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Purpose: To compare the efficacy and safety of fixed–combination latanoprost and timolol applied in the evening with the concomitant use of individual components. Methods: A randomized, double–masked, multicenter study included patients with ocular hypertension, open–angle, pigmentary, or exfoliation glaucoma. Baseline (after washout) intraocular pressure (IOP) levels were between 23 mmHg and 33 mmHg. Patients received either fixed combination (FC) of latanoprost and timolol once–daily in the evening and placebo in the morning and evening or unfixed combination (uFC) latanoprost once–daily in the evening and timolol morning and evening. Study visits were at weeks 2, 6, and 12. The primary efficacy endpoint was mean change from baseline to week 12 in diurnal IOP (mean IOPs of 8 am, 12 noon, 4 pm). FC was considered non–inferior to uFC if the upper limit of the 95% confidence interval (CI) of the difference was <1.5 mmHg (ANCOVA). Adverse events (AEs) were recorded at each visit. Results: Intent–to–treat analyses included 502 patients (FC, n=255; uFC, n=247). In the FC and uFC groups, mean baseline diurnal IOPs were 25.4 mmHg and 25.2 mmHg, respectively. Mean reductions in diurnal IOPs from baseline to week 12 were 8.7 mmHg and 9.0 mmHg, respectively; the between–treatment difference was 0.3 mmHg (95% CI, –0.1 to 0.7 mmHg [P=0.15]), indicating the FC was non–inferior to the uFC. For those receiving FC and uFC at 12 weeks, 93% and 92%, respectively, had a ≥20% reduction in mean diurnal IOP (P=0.58), while 76% and 74%, respectively, had mean diurnal IOP level ≤18 mmHg (P=0.52). Both treatments were well tolerated and safe; <3% of patients in either group withdrew from the study due to an AE. The FC group had fewer treatment–emergent AEs, ocular AEs, or eye irritations. Conclusions: The FC of latanoprost and timolol applied in the evening is non–inferior to the uFC of once nightly latanoprost and twice daily timolol. The FC provides a once–daily alternative to the three instillations needed with the individual components which may interfere with patient compliance.
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