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S. Giuffrida, A. Longo, V. Amico, M.G. Cro, M.G. Uva; Efficacy of a New Formulation of Timolol 0.5% in Sodium Hyaluronate Vehicle Administered Once Daily . Invest. Ophthalmol. Vis. Sci. 2003;44(13):2175.
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Purpose: to investigate the efficacy and safety of a new formulation of timolol 0.5% in a mucoadhesive vehicle of sodium hyaluronate (HA), administered once daily (FISER B105). Methods: Fourty patients affected with ocular hypertension or primary open angle glaucoma, well controlled (IOP< 18 mmHg) by monotherapy with beta-blockers, were included in a perspective, double-blind, controlled, randomized clinical trial. After a wash-out period of 4 weeks, baseline IOP was determined, then the patients were divided into two groups: Group A (20 patients, 9 M-11 F, mean age 62±10 years) was treated with FISER B105 in the morning and with vehicle of FISER B105 in the evening; Group B (20 patients, 10 M-10 F, mean age 60±11 years) was treated with timolol 0.5% BID. Measurements of the IOP (before and two hours after morning dosing of the eye drops), brachial artery blood pressure and heart rate, examination of anterior segment were performed at baseline (T0) and at day 7 (T7), day 30 (T30) and day 60 (T60) of treatment. At T0 and T60 patients were required to self-administer a symptoms questionnaire (Glaucoma Symptom Scale). Results: IOP values (mean + SD) measured before (0) and after 2 hours (2h) from morning dose are shown in the table: Both drugs reduced significantly the IOP (p=0.001, ANOVA). No significant differences were registered between the two groups in IOP, anterior segment examination, blood pressure and heart rate at all measurements. As regards the symptoms questionnaire, no difference was seen between the two groups at the baseline visit while at the final visit, the group A patients showed a lower incidence of four out of ten symptoms investigated by means of questionnaire (p<0.01, Chi-square test) (i.e. burning/stinging, dryness, itching, foreign body sensation). Conclusions: Fiser B105 administered once daily reduces the IOP in a comparable way with timolol 0.5% BID. These results could be due to the increased aqueous bioavailability of timolol when formulated in a mucoadhesive, viscoelastic HA vehicle in comparison with water solution. FISER B105 resulted also in a better tolerability. View OriginalDownload SlideView OriginalDownload Slide
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