Abstract
Purpose: :
To investigate the intraocular pressure (IOP) lowering effect of Bimatoprost 0.03% (BIM) and the potential additional effect of the Bimatoprost 0.03%/Timolol 0.5% fixed combination (BTFC) in eyes with ocular hypertension, primary open angle- or exfoliation glaucoma.
Methods: :
Following an appropriate wash-out period that varied according to previous medication, 25 patients with ocular hypertension, primary open angle or exfoliation glaucoma were treated with evening-dosed BIM for 5 weeks. Then, patients were given evening-dosed BTFC for another 5 weeks. Both eyes were treated but only one randomly-selected eye was evaluated. Goldmann applanation tonometry was performed by the same investigator at 8 a.m, 12 noon, 4 p.m. and 8 p.m. at baseline and at the end of each treatment period.
Results: :
Three patients discontinued due to local adverse effects. The mean diurnal IOP values (mean±SD) at baseline, on BIM and on BTFC were respectively 25.0±5.4 mmHg, 18.0±3.8 mmHg and 14.7±2.2 mmHg (repeated measures ANOVA, p<0.05 for all comparisons). The individual time-point IOP values showed similar significant reductions. The percentage IOP reduction from baseline was 27.9% for BIM and 39.0% for the BTFC. The mean±SD diurnal fluctuation was 6.7±3.3 mmHg at baseline, decreasing to 3.8±3.4 mmHg and 2.6±1.1 mmHg on BIM and BTFC respectively (p<0.05 for both treatments versus baseline).
Conclusions: :
Both Bimatoprost 0.03% and the Bimatoprost 0.03%/Timolol 0.5% fixed combination were effective in lowering intraocular pressure in eyes with ocular hypertension, primary open angle- or exfoliation glaucoma. However, the fixed combination provided an additional statistically significant reduction in intraocular pressure compared to Bimatoprost 0.03%.
Clinical Trial: :
www.clinicaltrials.gov NCT00941096
Keywords: intraocular pressure