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- Title
Efficacy and safety levels of preserved and preservative-free tafluprost are equivalent in patients with glaucoma or ocular hypertension: results from a pharmacodynamics analysis.
- Authors
Hamacher, Thomas; Airaksinen, Juhani; Saarela, Ville; Liinamaa, M. Johanna; Richter, Ulrich; Ropo, Auli
- 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.
- Subjects
PROSTAGLANDINS; EYE diseases; GLAUCOMA surgery; INTRAOCULAR pressure; PHARMACODYNAMICS
- Publication
Acta Ophthalmologica (1755375X), 2008, Vol 86, p14
- ISSN
1755-375X
- Publication type
Article
- DOI
10.1111/j.1755-3768.2008.01381.x