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L Jay Katz, Paul Kaufman, Tuyen Ong, Baldo Scassellati-Sforzolini, Jason Vittitow; Latanoprostene Bunod 0.024% Significantly Reduces and Maintains Mean Diurnal Intra-Ocular Pressure (IOP) Compared to Latanoprost 0.005% in Subjects with Open Angle Glaucoma or Ocular Hypertension. Invest. Ophthalmol. Vis. Sci. 2013;54(15):460.
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To evaluate and compare latanoprostene bunod (INN, USAN) 0.024% vs. latanoprost 0.005% ophthalmic solution in reducing and maintaining mean diurnal intraocular pressure (IOP) for up to 29 days in subjects with open angle glaucoma or ocular hypertension.
Only the latanoprostene 0.024% data are reported in this analysis; the dose-ranging data have been presented elsewhere. Following randomization, subjects were assigned to either latanoprostene bunod 0.024% (n=83) or latanoprost 0.005% ophthalmic solution (n=82). Enrollment in this dose ranging study consisted of eligible subjects with IOP ≥ 26 and ≤ 32 mmHg and a diagnosis of open-angle glaucoma or ocular hypertension. Subjects dosed once daily at 8PM for 28 days. Efficacy and safety evaluations occurred on Days 7, 14, 28, and 29. Efficacy assessments included mean diurnal IOPs and the proportion of subjects maintaining a mean diurnal IOP at ≤ 18 mmHg. Safety assessments included measurement of adverse events, best-corrected visual acuity, ocular tolerability, ocular signs, and vital sign measurements. An ANCOVA model with fixed-effect terms was performed. For the change from baseline IOP, t-tests were performed for all treatment groups.
Demographic and baseline characteristics were similar across treatment groups. Subjects had a mean age of 61.0 years, were predominantly white (77.6%), and female (66.7%) with 43.0% being naïve to treatment at the time of enrollment. At Days 7, 14, and 28, statistically greater reductions in mean diurnal IOPs were observed for latanoprostene bunod 0.024% compared with latanoprost 0.005% (8.3 vs. 7.3 mmHg, p = 0.0325; 8.9 vs. 7.7 mmHg, p = 0.0145; and 9.0 vs. 7.8 mmHg, p = 0.0051, respectively). Significantly more subjects in the latanoprostene bunod 0.024% group compared with the latanoprost 0.005% group had a study eye mean diurnal IOP ≤ 18 mmHg at Days 7 (p = 0.0057), 14 (p = 0.0464), 28 (p = 0.0061), and 29 (p = 0.026). All ocular treatment-emergent adverse events were mild or moderate in severity. The percentages of subjects with conjunctival hyperemia were similar across treatment groups.
Latanoprostene bunod 0.024% produced significantly greater reductions (~1 mmHg) in mean diurnal IOP for up to 29 days compared to latanoprost 0.005%.
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