Abstract
Aims
To compare intraocular pressure (IOP) reductions with fixed-combination (FC) latanoprost/timolol once daily in the evening vsFC dorzolamide/timolol twice daily.
Methods
This evaluator-masked, multicentre, controlled clinical trial randomized subjects with primary open-angle glaucoma or ocular hypertension with IOP insufficiently responsive to β-blocker therapy (screening IOP>21 and <37 mm Hg) to FC latanoprost–timolol (N=135) or FC dorzolamide/timolol (N=135). At screening, baseline, and after 4 and 12 weeks of therapy, IOP was measured three times at 0800, 1200, and 1600 hours. Adverse events were recorded at each visit. The primary efficacy end point was whether either FC could be shown to be inferior to the other with respect to change in mean daytime IOP from baseline to week 12.
Results
Mean daytime IOP levels were similar at baseline. Mean reductions in daytime IOP from baseline to week 12 were −9.7 mm Hg for FC latanoprost–timolol and −9.5 mm Hg for FC dorzolamide/timolol. The difference between FC latanoprost/timolol–FC dorzolamide–timolol was −0.2 mm Hg (95% confidence interval (CI), −0.8 to –0.4 mm Hg). The upper bound of the 95% CI was <1.5 mm Hg, indicating that neither FC is inferior to the other. However, a significantly greater percentage of subjects treated with FC latanoprost/timolol achieved IOP levels ⩽16 and ⩽15 mm Hg (P⩽0.01). Both treatments were well tolerated.
Conclusions
When β-blocker therapy is inadequate, either FC may achieve the desired IOP level, but FC latanoprost/timolol more oftenly achieves a pressure of ⩽16 mm Hg. Both FCs were well tolerated.
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Acknowledgements
Editorial support, including revising the paper based on author feedback and styling the paper for journal submission, was provided by Jane G Murphy, PhD, of Zola Associates. Gerald Bean, BS, an independent consultant and former employee of Pharmacia, Inc., critically reviewed the manuscript. Support for these activities was funded by Pfizer Inc., New York, NY, USA.
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Dr Grunden and Mr Kwok are employees of Pfizer Inc. Dr Miglior declares no conflict of interest.
Appendix A
Appendix A
Members of the Xalacom/Cosopt European Study Group
France: Dr med Philippe Denis, Hôpital Edouard Heriot, Lyon; Dr med Frederic Mouriaux, Hôpital Côte de Nacre, Caen; Dr med Guillaume Peigne, Polyclinique de Atlantique, Saint Herblain; Dr med Bernard Ridings, Hôpital De La Timme, Marseille; Dr med Daniele Rigal, Hôpital Gabriel Montpied, Clermont-ferrand.
Germany: Dr med Thomas Christ, Ophthalmology practice, Schorndorf; Dr med Heinrich Deuker, Ophthalmology practice, Darmstadt; Dr med Thomas Hamacher, Ophthalmology practice, Starnberg; Dr med Martin Hoffmann, Ophthalmology practice, Landau/Pfalz; Dr med Christoph Jelinek, Ophthalmology practice, Darmstadt; Dr med Maria-Luise Scherzer, Ophthalmology practice, Regenstauf.
Greece: Dr Konstandinos Karabatsas, University Hospital of Larisa, Larisa; Dr Anastassios Konstas, Ahepa General Hospital, Thessaloniki, Macedonia; Dr Vasilios Kozombolis, University Hospital of Alexandroupoli, Alexandroupoli; Dr Miltiadis Tsilimbaris, University Hospital of Heraklion, Heraklion, Crete.
Italy: Professor Roberto Carassa, Instituto S Raffaele/Clinica Oculistica Universitaria, Milano; Professor Nicola Delle Noci, Univerita de Foggia, Ospedali Riuniti, Foggia; Professor Michele Iester, Universita’ di Genova, Genova; Dr Leonardo Mastropasqua, Ospedale Clinicizzato Univeritaria i Chieti, Chieti; Professor Stefano Miglior, Universitaria Milano Biocca, Monza; Dr Marco Nardi, Ospedale S Chiaro A.O. Universitaria Pisana, Pisa.
Sweden: Dr Adnan Chatila, University Hospital, Ebro; Dr Anders Heijl, Malmö University Hospital, Malmö; Dr Bertil Lindblom, Sahlgren University Hospital, Molndal; Dr Lucian Vancea, Lanssjukhuset, Sundsvall.
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Miglior, S., Grunden, J., Kwok, K. et al. Efficacy and safety of fixed combinations of latanoprost/timolol and dorzolamide/timolol in open-angle glaucoma or ocular hypertension. Eye 24, 1234–1242 (2010). https://doi.org/10.1038/eye.2009.307
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DOI: https://doi.org/10.1038/eye.2009.307
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