gms | German Medical Science

104th DOG Annual Meeting

21. - 24.09.2006, Berlin

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New bimatoprost/timolol fixed combination as effective as non-fixed concurrent therapy in glaucoma/ocular hypertension

Meeting Abstract

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  • A. B. Hommer - University of Vienna, Department of Ophthalmo-Pharmacology, Vienna, Austria
  • C. Chou - Allergan, Inc., Irvine, USA
  • A. Ingram - Allergan, Inc., Irvine, USA

Deutsche Ophthalmologische Gesellschaft e.V.. 104. Jahrestagung der Deutschen Ophthalmologischen Gesellschaft (DOG). Berlin, 21.-24.09.2006. Düsseldorf, Köln: German Medical Science; 2006. Doc06dogP297

The electronic version of this article is the complete one and can be found online at: http://www.egms.de/en/meetings/dog2006/06dog819.shtml

Published: September 18, 2006

© 2006 Hommer et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by-nc-nd/3.0/deed.en). You are free: to Share – to copy, distribute and transmit the work, provided the original author and source are credited.

Outline

Text

Objective

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.

Methods

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.

Results

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).

Conclusions

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.