Efficacy and Tolerability of Travoprost 0.004-Timolol 0.5 Fixed-Dose Combination for the Treatment of Primary Open-Angle Glaucoma or Ocular Hypertension Inadequately Controlled with Beta-Blocker MonotherapyReportar como inadecuado




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Journal of Ophthalmology - Volume 2017 2017, Article ID 1917570, 8 pages - https:-doi.org-10.1155-2017-1917570

Clinical Study

Organización Medica de Investigación OMI, Buenos Aires, Argentina

Fundación para el Estudio del Glaucoma, Buenos Aires, Argentina

Seoul National University Hospital, Seoul, Republic of Korea

Alcon Research, Ltd., Fort Worth, TX, USA

Research Institute of Eye Diseases, Moscow, Russia

Instituto de Oftalmologia y Ciencias Visuales, CUCS, Universidad de Guadalajara, Guadalajara, JAL, Mexico

Unidad de Diagnostico Temprano del Glaucoma, Global Glaucoma Institute Occidente, Guadalajara, JAL, Mexico

Sydney Medical School, University of Sydney, Sydney, NSW, Australia

Vision Eye Institute, Sydney, NSW, Australia

Correspondence should be addressed to Simon Fabian Lerner

Received 21 September 2016; Revised 13 December 2016; Accepted 29 December 2016; Published 23 January 2017

Academic Editor: Tamer A. Macky

Copyright © 2017 Simon Fabian Lerner et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Objective. To evaluate the efficacy and tolerability of travoprost 0.004%-timolol 0.5% fixed-dose combination TTFC in patients with open-angle glaucoma OAG or ocular hypertension OHT inadequately controlled on beta-blocker monotherapy. Methods. In this phase IV, open-label study, 156 patients on beta-blocker monotherapy with mean intraocular pressure IOP between 18 and 32 mmHg were randomized no washout period to receive TTFC for 8 weeks TTFC group or to continue beta-blocker monotherapy for 4 weeks followed by TTFC for the remaining 4 weeks beta-blocker group. Results. The mean IOP ±standard deviation at baseline in the TTFC and beta-blocker groups was  mmHg and  mmHg, respectively, and at weeks 4 and 8, was  mmHg and  mmHg, respectively, in TTFC group and  mmHg and  mmHg, respectively, in the beta-blocker group. There was a significant least squares mean difference between TTFC and beta-blocker in 8 a.m. IOP at week 4 −4.6 mmHg; one-sided 95% confidence interval −inf, −3.9; primary endpoint; the upper bound of the 95% confidence interval was within the prespecified limit <0. Both treatments were well tolerated. Conclusion. Superior IOP control was achieved with TTFC in patients with OAG or OHT previously uncontrolled with beta-blockers. No new safety findings were identified. This trial is registered with ClinicalTrials.gov NCT02003391.





Autor: Simon Fabian Lerner, Ki Ho Park, Douglas A. Hubatsch, Valeriy Erichev, Jose A. Paczka, and Timothy V. Roberts

Fuente: https://www.hindawi.com/



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