1755-3768/asset/olbannercenter.gif?v=1&s=baf172706d8b0315485b0acf45bb6cfebe7a6ecc)
Efficacy and safety levels of preserved and preservative-free tafluprost are equivalent in patients with glaucoma or ocular hypertension: results from a pharmacodynamics analysis
Article first published online: 22 AUG 2008
DOI: 10.1111/j.1755-3768.2008.01381.x
© 2008 The Authors. Journal compilation © 2008 Acta Ophthalmol
Issue
Acta Ophthalmologica
Special Issue: Tafluprost: a novel preservative-free prostaglandin analogue for the treatment of glaucoma or ocular hypertension
Volume 86, Issue Supplement s242, pages 14–19, September 2008
Additional Information
How to Cite
Hamacher, T., Airaksinen, J., Saarela, V., Liinamaa, M. J., Richter, U. and Ropo, A. (2008), Efficacy and safety levels of preserved and preservative-free tafluprost are equivalent in patients with glaucoma or ocular hypertension: results from a pharmacodynamics analysis. Acta Ophthalmologica, 86: 14–19. doi: 10.1111/j.1755-3768.2008.01381.x
Publication History
- Issue published online: 22 AUG 2008
- Article first published online: 22 AUG 2008
- Received on 18 June, 2008. Accepted on 3 July, 2008.
- Abstract
- Article
- References
- Cited By
Keywords:
- benzalkonium chloride;
- glaucoma;
- intraocular pressure;
- preservative-free;
- tafluprost
Abstract.
Purpose: Tafluprost is a new prostaglandin F2α (PGF2α) derivative in development for the treatment of glaucoma. Tafluprost is the first PGF2α analogue with a preservative-free formulation.
Methods: This randomized, investigator-masked, multicentre, crossover phase III study evaluated the pharmacodynamics and safety of preserved and preservative-free tafluprost 0.0015% eyedrops administered for 4 weeks in 43 patients with open-angle glaucoma or ocular hypertension. The primary variable was change from baseline in overall diurnal intraocular pressure (IOP) at 4 weeks. Adverse events and other safety parameters were also analysed.
Results: Decreased IOP was clearly observed with both formulations at week 1 and was sustained until week 4. The overall treatment difference (preservative-free versus preserved formulations) at week 4 was 0.01 mmHg (95% confidence interval − 0.46 to 0.49; p = 0.96). There were no unexpected safety-related findings. Both formulations were well tolerated and most adverse events were ocular and mild in severity.
Conclusions: The reduction in IOP achieved by preservative-free tafluprost is equivalent to that obtained with the preserved formulation. The preservative-free formulation was generally well tolerated.