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To compare the efficacy and safety of unoprostone versus brimonidine both given twice daily in ocular hypertensive or primary open-angle glaucoma subjects. After a 1-month washout period a baseline diurnal curve was measured every 2 hours from 08 : 00 hours (trough) to 20 : 00 hours in subjects with a trough intraocular pressure (IOP) and the pressure 24 mmHg. Qualified subjects were randomized to either brimonidine or unoprostone. After 6 weeks of treatment the period 1 diurnal curve was performed. Subjects were then switched to the opposite treatment for 6 weeks and the period 2 diurnal curve was performed. A total of 33 subjects were included in this study. In the brimonidine-treated group the trough IOP 20.1 ± 2.8 mmHg was reduced from baseline up to 8 hours after dosing. In the unoprostone-treated group the trough IOP was 19.5 ± 3.0 mmHg, which was statistically equal to that of brimonidine (p = 0.21), was reduced from baseline for 12 hours after dosing. Brimonidine decreased the IOP statistically more than unoprostone at 10 : 00 and 12 : 00 hours (p < 0.0001 and p = 0.02, respectively), while unoprostone reduced the IOP more than brimonidine at 18 : 00 and 20 : 00 hours (p = 0.002 and p = 0.05, respectively). Safety levels were similar between groups, but unoprostone caused more ocular stinging than brimonidine (p = 0.008). This study suggests that twice daily brimonidine demonstrates a statistically greater peak reduction in IOP than unoprostone. However, unoprostone, but not brimonidine, decreased IOP over the complete 12-hour daytime dosing cycle. [ABSTRACT FROM AUTHOR]

ABSTRACT. Purpose: To compare the cardiovascular effects of unoprostone 0.15%, timolol 0.5% and placebo in healthy adults during exercise using a treadmill test. Methods: Thirty subjects aged 18–37 years (mean age = 24.1 years) were randomized to one of six treatment sequences in a three-treatment, three-period crossover study (William's design). Study medication was instilled b.i.d. for 5 days before visits 2, 3, and 4. Between treatments, study medication was washed out for 9–10 days. Each subject underwent a submaximal treadmill test at visits 2 through 4, 15 min after dosing. Results: After 15 min of exercise, average heart rates were 143.1 ± 21.2, 134.5 ± 20.0 and 145.4 ± 20.8 bpm for the unoprostone, timolol and placebo treatments, respectively. At no timepoint was there a statistically significant difference between the unoprostone and placebo treatments (p > 0.05). Beginning with the second minute of exercise, timolol produced a greater decrease in heart rate at all timepoints from placebo than unoprostone (p < 0.05). No consistent differences in systolic or diastolic blood pressure were observed between drug treatments (p > 0.05). Conclusions: Unlike timolol, unoprostone 0.15% does not reduce exercise-induced heart rate, indicating a lack of clinical effect on systemic β -adrenergic receptors in young and healthy subjects. [ABSTRACT FROM AUTHOR]