A Double-Masked,Randomized,Parallel Comparison of a Fixed Combination of Bimatoprost 0.03%/Timolol 0.5% with Non-Fixed Combination use in Patients with Glaucoma or Ocular Hypertension

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)