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
Abstract
PURPOSE: 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 betablocker 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 at baseline in the TTFC and betablocker groups was 22.5±2.5 mmHg and 22.2±2.3 mmHg, respectively, and at weeks 4 and 8, was 16.7±3.1 mmHg and 16.1±3.1 mmHg, respectively, in TTFC group and 21.1±3.1 mmHg and 16.1±2.8 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; ????0.0001). 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.
About the Authors
S. F. Lerner
Organizaci n Medica de Investigaci n, Buenos Aires, Argentina;
Fundaci n para el Estudio del Glaucoma, Buenos Aires, Argentina
Argentina
Argentina
K. H. Park
Seoul National University Hospital, Seoul, Republic of Korea
Korea, Republic of
Korea, Republic of
D. A. Hubatsch
Alcon Research, Ltd., FortWorth, TX, USA
United States
United States
V. P. Erichev
Research Institute of Eye Diseases
Russian Federation
Russian Federation
J. A. Paczka
Instituto de Oftalmologia y Ciencias Visuales, Guadalajara, Mexico;
Unidad de Diagnostico Temprano del Glaucoma, Global Glaucoma Institute Occidente, Guadalajara, Mexico
Mexico
Mexico
T. V. Roberts
Sydney Medical School, University of Sydney, Sydney, Australia;
Vision Eye Institute, Sydney, Australia
Australia
Australia
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Review
For citations:
Lerner S.F., Park K.H., Hubatsch D.A., Erichev V.P., Paczka J.A., Roberts T.V. 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. National Journal glaucoma. 2017;16(3):18-27. (In Russ.)
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