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

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 Monotherapy

1Organización Medica de Investigación (OMI), Buenos Aires, Argentina
2Fundación para el Estudio del Glaucoma, Buenos Aires, Argentina
3Seoul National University Hospital, Seoul, Republic of Korea
4Alcon Research, Ltd., Fort Worth, TX, USA
5Research Institute of Eye Diseases, Moscow, Russia
6Instituto de Oftalmologia y Ciencias Visuales, CUCS, Universidad de Guadalajara, Guadalajara, JAL, Mexico
7Unidad de Diagnostico Temprano del Glaucoma, Global Glaucoma Institute Occidente, Guadalajara, JAL, Mexico
8Sydney Medical School, University of Sydney, Sydney, NSW, Australia
9Vision Eye Institute, Sydney, NSW, Australia

Correspondence should be addressed to Simon Fabian Lerner; ra.moc.oohay@samocualg

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.