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F. Oddone, M. Centofanti, S. A. Gandolfi, A. B. Hommer, A. G. Boehm, L. Tanga, C. Sangermani, V. Sportelli, G. Manni, L. Rossetti; Comparing Prostaglandin Analogues Plus Timolol Fixed Combinations for the Treatment of Open Angle Glaucoma. The Glaucoma Randomized European Assessment Trial. Invest. Ophthalmol. Vis. Sci. 2010;51(13):6433.
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To investigate and compare the efficacy and safety of the fixed combinations of bimatoprost and travoprost plus timolol (BTFC and LTFC) in open angle glaucoma patients (OAG) under treatment with latanoprost and timolol fixed combination.
Eighty-nine OAG patients were included in this multicentre, prospective, randomized, double masked, cross-over clinical trial. After 6 weeks run-in period with LTFC, patients were allocated to be treated with either TTFC or BTFC for 3 months. After 3 months patients switched to the opposite therapy for 3 more months. The primary endpoint was the comparison of mean daily intraocular pressure (IOP) after 3 months of each treatment.
baseline IOP was 16.5 mmHg (95%CI 16.0-17.0) under treatment with LTFC. Both BTFC and TTFC reduced the mean IOP from baseline (p<0.0001). After 3 months of each treatment mean IOP was significantly lower in BTFC group compared to TTFC group (14.7 [14.3-15.3] vs 15.4 mmHg [15.0-15.9], p=0.0041). IOP was lower during BTFC treatment at all time points and statistical significance was reached at 8am, 11am, 5pm but not at 2pm and 8pm. The safety profile was similar between groups.
both BTFC and TTFC are effective in reducing the IOP in patients not fully controlled with LTFC. The observed additional IOP reduction was greater with BTFC with similar safety profile.
Clinical Trial: :
EUDRACT # 2007-004023-38
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