Abstract
Background
To compare the efficacy and safety of timolol 0.5% versus brinzolamide 1.0% when added to travoprost monotherapy in patients with primary open-angle glaucoma or ocular hypertension.
Methods
Patients meeting selection criteria (IOP one eye 19 mmHg and ≤32 mmHg and IOP both eyes ≤32 mmHg at 8:00 h) were switched to travoprost monotherapy for 4 weeks. Patients then insufficiently controlled on travoprost (IOP at 8:00 h ≥19 mmHg) at baseline were randomized to receive either travoprost and brinzolamide or travoprost and timolol in a double-masked fashion for 12 weeks.
Results
Two hundred and fifty-three patients underwent the 4-week run-in period. Switching to travoprost resulted in adequate IOP control (<19 mmHg) for 21.7% of patients. After 3 months of treatment, both drug combinations statistically significantly reduced the mean IOP at each time point (8:00, 12:00 and 16:00 h) and the mean diurnal IOP, which was 17.9 ± 2.6 mmHg for the brinzolamide group and 17.0 ± 3.2 mmHg for the timolol group. Both combinations were well-tolerated. However, a statistically significant difference occurred at 16:00 h, with pressures of 16.4 ± 3.2 mmHg and 17.3 ± 2.8 mmHg for the timolol and brinzolamide groups, respectively (p = 0.038). Fifty percent of patients reported one adverse event, whereas in 13.2% three or more adverse effects were named. Hyperemia was found most often (6.3% of the patients).
Conclusion
Both adjunctive combinations moderately reduced IOP in patients inadequately controlled with travoprost monotherapy, with timolol being slightly stronger 8 hours after instillation. Adjunctive treatment with brinzolamide and travoprost may be an alternative for patients not tolerant or not responsive to treatment with timolol and travoprost.
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Acknowledgments
The Study was sponsored by Alcon, Forth Worth, TX, USA. The company only had influence on the design of the study. The collection, management, analysis and interpretation of the data were investigator driven. The study group had no financial relationship (e.g., contractors, consultants, stockholders) to the sponsor.
Investigators and co-investigators of the TATS study group
Philippe Denis, Cornut Pierre-Loïc (Department of Ophthalmology, Hôpital Edouard Herriot, Lyon, France); Yves Lachkar, Aoife Doyle (Department of Ophthalmology, Institut du Glaucome, Hopital St Joseph, Paris, France); Silke Kinnebrock, Marlene Maser-Wahle (Department of Ophthalomology, Augenklinik und Universität Mainz, Mainz, Germany); Ines Lanzl, Andreas Pichler (Department of Ophthalomology, Augenklinik und Poliklinik der, Technischen Universität München, München, Germany); Klaus-Dieter Quentin, Sandra Hache (Department of Ophthalmology, Universitätsaugenklinik Göttingen, Göttingen, Germany); Christian Vorwerk, Cordula Pump-Schmidt (Department of Ophthalmology, Otto von Guericke Universität, Magdeburg, Germany); Ilse Strempel, Claudia Knop (Department of Ophthalmology, Klinikum der Philipps-Universität, Marburg, Germany); Carl Erb, Michael Meyer (Department of Ophthalmology, Medizinische Hochschule, Hannover, Germany); Giancarlo Bertoni, Blini Mirella, Alessandro David, Daniella Salerno (Department of Ophthalmology, U.O. Oculistica Azienda Ospedaliera L. Sacco-Polo Universitario, Milano, Italy); Renato Alberto Meduri, Lucia Scorolli, Sergio Zaccaria Scanlinci, Daniela Giardina (Centro per la Prevenzione del Glaucoma, Dipartamento de Scienze Chirurgiche ed Anestesiologiche, Università degli Studi di Bologna, Policlinico S. Orsola-Malpigui, Bologna, Italy); Alessandro Galan (Department of Ophthalmology, U.O.C. di Oculistica, Hospédale S. Antonio Abate, Padova, Italy); Antonio Martínez García (Department of Ophthalmology, Fundación Pública Instituto Galego de Oftalmoloxia, Hospital Provincial de Conxo, Santiago de Compostela, Spain); Manuel Díaz Llopis, Salvador García-Delpech, María García-Pous (Department of Ophthalmology, Hospital General Universitario de Valencia, Spain); Francisco Honrubia, Luis Pablo, LM Larrosa, V Polo (Hospital Universitario Miguel Servet, Zaragoza, Spain); Susana Duch Tuesta, Elena Milla (Department of Ophthalmology, Instituto Condal de Oftalmología, Barcelona, Spain).
Preparation of the study and manuscript writing
Norbert Pfeiffer, Sabine Kurz (Department of Ophthalmology, Augenklinik und Universität Mainz, Mainz, Germany)
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The Study was sponsored by Alcon, Forth Worth, Texas, USA
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Pfeiffer, N., The TATS (Travatan Adjunctive Treatment Study) group. Timolol versus brinzolamide added to travoprost in glaucoma or ocular hypertension. Graefes Arch Clin Exp Ophthalmol 249, 1065–1071 (2011). https://doi.org/10.1007/s00417-011-1650-8
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DOI: https://doi.org/10.1007/s00417-011-1650-8