Abstract
Purpose
To compare the safety and efficacy of the fixed combination product with nonfixed combination use of the same active ingredients in separate bottles (bimatoprost oncedaily [qd], and timolol twice-daily [bid]). A bimatoprost 0.03% qd treatment arm was used for validation of the study.
Methods
This was a double-masked, randomized, parallel study in 445 patients with open-angle glaucoma or ocular hypertension. They were randomized in a ratio of 2:2:1 to receive bilateral treatment with the fixed combination, non-fixed combination treatment, or bimatoprost alone.
Results
Comparing the fixed combination and non-fixed combination, the non-inferiority margin of 1.5 mmHg was met at all three timepoints for mean intraocular pressure (IOP), and a margin of 1.0 mmHg for mean diurnal IOP. The incidence of conjunctival hyperemia was statistically significantly lower (p=0.014) in the fixed combination group (8.5%, 15/176) compared with the bimatoprost group (18.9%, 17/90) and the non-fixed combination group (12.5%, 22/176).
Conclusions
The fixed combination of bimatoprost 0.03%/timolol 0.5% administered once daily was comparable in ocular hypotensive efficacy to the non-fixed combination. The lower propensity of the fixed combination to elicit conjunctival hyperemia suggests a superior comparative benefit/risk assessment of the fixed combination in the treatment of elevated IOP. (Eur J Ophthalmol 2007; 17: 53–62)