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J Schuhr, JA Stewart, DG Day, JN Leech, WC Stewart; The Safety and Efficacy of Unoprostone Isopropyl 0.15% Versus Brimonidine 0.2% . Invest. Ophthalmol. Vis. Sci. 2002;43(13):3433.
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Purpose: To evaluate the efficacy and safety of unoprostone 0.15% versus brimonidine 0.2%, each given twice daily, in patients with ocular hypertension or primary open-angle glaucoma. Methods: After a washout period of one month, a baseline diurnal curve was measured every two hours from 08:00 to 20:00, in patients with a trough intraocular pressure ≥ 24 mm Hg. Qualified patients were randomized to either brimonidine or unoprostone. After six weeks of treatment a Period I diurnal curve was performed. Patients then were switched to the other medicine for six weeks before a Period II diurnal curve was completed. Results: In 33 completed patients, the mean untreated diurnal baseline was 21.6 3.9 mm Hg. Brimonidine demonstrated a diurnal intraocular pressure of 18.5 3.7 with a trough of 20.1 2.8 mm Hg. Unoprostone showed a diurnal intraocular pressure of 18.6 3.6 and a trough pressure of 19.5 3.0 mm Hg. These values were statistically equal between groups (P = 0.92 and P = 0.22 respectively). Brimonidine reduced the pressure from baseline up to eight hours after morning dosing and unoprostone reduced the intraocular pressure from baseline for 12 hours after dosing. Brimonidine decreased the pressure statistically more than unoprostone at two and four hours after dosing (P < 0.0001 and P = 0.02, respectively) while unoprostone reduced the pressure more than brimonidine at 10 and 12 hours after dosing (P = 0.005 and P = 0.02, respectively). Safety was similar between groups, but unoprostone caused more ocular stinging than brimonidine (P = 0.008). Conclusion: When dosed BID the diurnal and trough pressures for brimonidine and unoprostone were found to be statistically equal. Twice daily brimonidine demonstrated a statistically greater peak reduction in intraocular pressure than unoprostone. Unoprostone had a statistically greater pressure reduction than brimonidine at 10 and 12 hours post dosing.
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