Efficacy and safety of tafluprost in normal-tension glaucoma with intraocular pressure of 16 mmHg or less.

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.