Aim: To evaluate the efficacy and tolerability of flunarizine, a nonselective calcium channel blocker, on intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OH).
Design: Randomized, placebo-controlled, double blind, cross-over phase II trial.
Methods: Ten patients diagnosed with bilateral OAG or OH were included. Each patient served as his own control. On the first study visit, 1 drop of either 0.05% flunarizine or placebo was applied in the study eye. Patients were followed-up during 6 hours (0, 15, 30, and 60 min, 2, 3, 4, and 6 h) for vital signs, slit lamp examination, corneal fluorescein staining, and IOP. After a wash-out period of 4 weeks, 1 drop of either placebo or flunarizine was applied in the same eye and patients were followed-up for another 6 hours.
Results: The flunarizine group showed a statistically significant decrease from baseline at T2, T3, T4, and T6 hours (P=0.01, P=0.03, P=0.01, and P=0.03, respectively). No significant difference in IOP decrease from baseline (P>0.06) was observed between the 2 groups. There was no statistically significant difference in all of the following parameters: limbal hyperemia, bulbar or palpebral conjunctival hyperemia, corneal staining with fluorescein, best-corrected visual acuity, comfort of eye drops, and vital signs.
Conclusions: The absence of a statistically significant difference in IOP reduction between the 2 groups may be due to the small number of patients included. However, a single dose of 0.05% flunarizine significantly reduced IOP when compared with baseline values, whereas this was not observed with placebo.