PURPOSE: To evaluate the intraocular pressure (IOP)-reducing effects and safety of 0.0015% tafluprost ophthalmic solution (tafluprost) in normal-tension glaucoma (NTG) patients with an IOP of 16 mmHg or less. METHODS: NTG patients with a baseline IOP of 16 mmHg or less were enrolled for a one-eye study in which tafluprost was applied once daily for 12 weeks. The presence of adverse drug reactions and the cumulative incidence of adverse events were also investigated. RESULTS: Among the 44 enrolled patients, 41/44 (93.2%) eyes completed the study. The baseline IOP was 13.2 ± 1.3 mmHg in the study eyes and 13.0 ± 1.3 mmHg in the fellow eyes, which was not statistically significant (P = 0.9173, Student's t test). The values obtained for IOP in the study eyes versus fellow eyes were 10.2 ± 1.6 versus 12.1 ± 1.5 mmHg at week 12. The IOP difference between the study eyes and the fellow eyes was statistically significant (P < 0.0001, Student's t test). The cumulative incidence of adverse events was 58.5% by week 12. Ocular itching was the most frequently observed adverse event (29.3%). All adverse events were clinically tolerable. CONCLUSIONS: Tafluprost induced significant IOP reductions in NTG patients with a baseline IOP of 16 mmHg or less without raising any safety concerns.
PURPOSE: To evaluate the intraocular pressure (IOP)-reducing effects and safety of 0.0015% tafluprost ophthalmic solution (tafluprost) in normal-tension glaucoma (NTG) patients with an IOP of 16 mmHg or less. METHODS: NTG patients with a baseline IOP of 16 mmHg or less were enrolled for a one-eye study in which tafluprost was applied once daily for 12 weeks. The presence of adverse drug reactions and the cumulative incidence of adverse events were also investigated. RESULTS: Among the 44 enrolled patients, 41/44 (93.2%) eyes completed the study. The baseline IOP was 13.2 ± 1.3 mmHg in the study eyes and 13.0 ± 1.3 mmHg in the fellow eyes, which was not statistically significant (P = 0.9173, Student's t test). The values obtained for IOP in the study eyes versus fellow eyes were 10.2 ± 1.6 versus 12.1 ± 1.5 mmHg at week 12. The IOP difference between the study eyes and the fellow eyes was statistically significant (P < 0.0001, Student's t test). The cumulative incidence of adverse events was 58.5% by week 12. Ocular itching was the most frequently observed adverse event (29.3%). All adverse events were clinically tolerable. CONCLUSIONS:Tafluprost induced significant IOP reductions in NTG patients with a baseline IOP of 16 mmHg or less without raising any safety concerns.