Abstract
Purpose: To evaluate the effect of 6 weeks administration of beclomethasone nasal spray on intraocular pressure (IOP) in patients with ocular hypertension or controlled primary open-angle glaucoma.
Patients and Methods: Randomized double-masked controlled trial. Patients were randomized to twice daily beclomethasone versus placebo saline nasal spray. There were a total of 4 study visits: baseline and weeks 2, 4, 6 after starting the spray. Each study visit was at the same time within a 1-hour time window. Primary outcome measure was IOP. Secondary measures included visual acuity, anterior segment changes, patient reported side effects, and compliance. Study endpoint was 6 weeks from the start of treatment or an IOP increase of > 20% from baseline. A sample size calculation suggested that 8 patients in each arm would be sufficient to detect a difference of 3.2mm Hg with a power of 80%.
Results: Nineteen consecutive consenting patients completed the study-9 in the steroid arm and 10 in the placebo arm. There were no statistically significant differences between groups in baseline characteristics, IOP at each study visit, or change in IOP from baseline at any time point. At 6 weeks, the change in mean IOP from baseline was + 0.50 +/- 1.52 versus + 0.70 +/- 1.44 mm Hg in the steroid and saline nasal spray groups, respectively (P=0.77).
Conclusions: Patients with ocular hypertension and primary open-angle glaucoma showed no evidence of IOP elevation after 6 weeks use of beclomethasone nasal spray.