title: 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.
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 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; one-sided 95% confidence interval [-inf, -3.9];p< 0.0001 [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.
authors.affiliation: Organización Medica de Investigación (OMI), Buenos Aires, Argentina; Fundación para el Estudio del Glaucoma, Buenos Aires, Argentina.
authors.forename: Simon Fabian
authors.identifier: 0000-0002-4657-286X
authors.initials: SF
authors.lastname: Lerner
authors.affiliation: Seoul National University Hospital, Seoul, Republic of Korea.
authors.forename: Ki Ho
authors.initials: KH
authors.lastname: Park
authors.affiliation: Alcon Research, Ltd., Fort Worth, TX, USA.
authors.forename: Douglas A
authors.initials: DA
authors.lastname: Hubatsch
authors.affiliation: Research Institute of Eye Diseases, Moscow, Russia.
authors.forename: Valeriy
authors.initials: V
authors.lastname: Erichev
authors.affiliation: 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.
authors.forename: Jose A
authors.initials: JA
authors.lastname: Paczka
authors.affiliation: Sydney Medical School, University of Sydney, Sydney, NSW, Australia; Vision Eye Institute, Sydney, NSW, Australia.
authors.forename: Timothy V
authors.initials: TV
authors.lastname: Roberts