gms | German Medical Science

To evaluate the safety and efficacy of a fixed combination of bimatoprost 0.03% and timolol 0.5%, q.d., AM, versus non-fixed concurrent use of each component separately (bimatoprost q.d., PM and timolol b.i.d.), and bimatoprost q.d. PM.

This multinational, double-masked, randomized, parallel study recruited 445 patients at 35 sites worldwide. Masking was maintained with the use of bottles containing vehicle. Patients with ocular hypertension or glaucoma (open-angle, pseudoexfoliative, pigmentary or narrow-angle post iridectomy/iridotomy), naïve to pharmacotherapy, with IOP of 24 to 34 mm Hg were enrolled. Post randomization visit performed at week 3 with IOP assessed at 08:00, 10:00 and 16:00 hours and full ocular and non ocular safety.

Disposition: Completing the study successfully were 96.6% (430/445) of patients.

Efficacy: No baseline among-group differences observed for any parameters; baseline 08:00 hours IOP of between 26.2 and 26.4 mm Hg. At week 3, all three treatments provided substantial decrease in IOP. The fixed combination was non-inferior to non-fixed concurrent treatment, with the mean IOP between group difference within the 1.5 mm Hg 95% CI margin at all three timepoints. The fixed combination resulted in a change from baseline mean diurnal IOP of 8.8 mm Hg and was statistically significantly more effective than bimatoprost alone (by 0.8 mm Hg, p<0.05).

Safety: No unexpected or serious adverse events were reported for any treatment. The most frequently reported ocular side effects in the study was conjunctival hyperemia, interestingly reported less frequently in the fixed combination (19.3%, 34/176) group than in either the non-fixed concurrent (25.6%, 45/176) or the bimatoprost (27.8%, 25/90) groups. Other frequently reported ocular side effects were burning/stinging in eye, eye pruritus, visual disturbance and foreign body sensation. The incidence of burning sensation in the eye were statistically significantly (p=0.024) lower with the fixed combination (6.8%, 12/176) compared with non-fixed concurrent use (14.2%, 25/176).

The ocular hypotensive efficacy of the bimatoprost/ timolol fixed combination was non-inferior to that achieved by the non-fixed concurrent use of the two drugs. The fixed combination provided additional efficacy to that of bimatoprost alone. The combination treatment also has a greater safety potential with respect to ocular adverse events like hyperemia and comfort.