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
Joint Authors
Park, Ki H.
Hubatsch, Douglas A.
Lerner, Simon Fabian
Erichev, Valeriy
Paczka, Jose A.
Roberts, Timothy V.
Source
Issue
Vol. 2017, Issue 2017 (31 Dec. 2017), pp.1-8, 8 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2017-01-23
Country of Publication
Egypt
No. of Pages
8
Main Subjects
Abstract EN
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.
American Psychological Association (APA)
Lerner, Simon Fabian& Park, Ki H.& Hubatsch, Douglas A.& Erichev, Valeriy& Paczka, Jose A.& Roberts, Timothy V.. 2017. 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. Journal of Ophthalmology،Vol. 2017, no. 2017, pp.1-8.
https://search.emarefa.net/detail/BIM-1184582
Modern Language Association (MLA)
Lerner, Simon Fabian…[et al.]. 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. Journal of Ophthalmology No. 2017 (2017), pp.1-8.
https://search.emarefa.net/detail/BIM-1184582
American Medical Association (AMA)
Lerner, Simon Fabian& Park, Ki H.& Hubatsch, Douglas A.& Erichev, Valeriy& Paczka, Jose A.& Roberts, Timothy 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 Monotherapy. Journal of Ophthalmology. 2017. Vol. 2017, no. 2017, pp.1-8.
https://search.emarefa.net/detail/BIM-1184582
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-1184582