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C.S. Tressler, R. Susanna, Jr., Latin American Latanoprost Study Group; Latanoprost and Fixed Combination Dorzolamide + Timolol in Patients With Elevated Intraocular Pressure. An 8-week, Open-label, Multicenter Study in Latin America . Invest. Ophthalmol. Vis. Sci. 2003;44(13):4370.
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Purpose: To compare the IOP reducing effect and safety of once-daily latanoprost with the fixed combination of dorzolamide + timolol given twice daily for 8 weeks. Methods: Patients with primary open-angle glaucoma or exfoliative glaucoma (baseline IOP≥ 21 mmHg) or ocular hypertension (baseline IOP≥ 25 mmHg) were randomized to latanoprost once daily in the evening or fixed combination dorzolamide + timolol twice daily (morning and evening). No other IOP-reducing medication was permitted. At baseline and after 8 weeks of therapy, evaluators measured IOP in triplicate at 8:30 AM, 10 AM, 2 PM, and 5 PM and after the water-drinking test (performed following the 5 PM IOP assessment). Adverse event data were recorded. The primary efficacy outcome was change in diurnal IOP from baseline to Week 8 (analyzed with ANCOVA). Results: 229 patients were randomized (112, latanoprost; 117, dorzolamide + timolol). Mean diurnal IOPs at baseline were similar (about 23.5 mmHg). Mean ± SD diurnal IOP at Week 8 was 16.6 ± 3.02 mmHg (29.3% reduction) in latanoprost vs 17.2 ± 3.10 mmHg (26.5% reduction) in dorzolamide + timolol patients (adjusted between group difference: 0.58 mmHg; 95% CI: -0.096,1.257). Adjusted differences in IOP reductions ranged from 0.35 to 0.84 mmHg at the various measurement times in favor of latanoprost (significant at 5 PM). Rise in IOP after water drinking was similar between groups at baseline but significantly lower in the latanoprost group at Week 8 (estimated between group difference: 1.08 mmHg; 95% CI: 0.24,1.93). Ocular adverse events were reported in 3.6% of latanoprost patients vs 12.0% of dorzolamide + timolol patients; systemic adverse events were reported in 7.1% vs 24.8% of patients, respectively. Conclusions: After 8 weeks of treatment, the mean diurnal IOP was lower in latanoprost-treated patients, although the between-treatment difference was not significant. Latanoprost patients had significantly less IOP elevation following the water-drinking test and exhibited better ocular and systemic profiles than those treated with fixed combination dorzolamide + timolol.
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