Efficacy and tolerability of topical 0.05% flunarizine in patients with open-angle glaucoma or ocular hypertension-a pilot study.
OBJECTIVE
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).


METHODS
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.
Glaucoma Sector, Ophthalmology Clinic, University of Geneva, Geneva, Switzerland. kawehm@yahoo.com
Kaweh
K
Mansouri
Sergio Estrela
SE
Silva
Tarek
T
Shaarawy
D000287:Administration, Topical; D001794:Blood Pressure / Q000187:drug effects; D002121:Calcium Channel Blockers / Q000008:administration & dosage* / Q000009:adverse effects; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D005444:Flunarizine / Q000008:administration & dosage* / Q000009:adverse effects; D005902:Glaucoma, Open-Angle / Q000188:drug therapy*; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects*; D008297:Male; D008875:Middle Aged; D009798:Ocular Hypertension / Q000188:drug therapy; D010865:Pilot Projects; D014065:Tonometry, Ocular; D016896:Treatment Outcome
D002121:Calcium Channel Blockers; D005444:Flunarizine