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Randomized, Controlled, Phase 3 Trials of Carteolol/Latanoprost Fixed Combination in Primary Open-Angle Glaucoma or Ocular Hypertension.

Authors :
Yamamoto T
Ikegami T
Ishikawa Y
Kikuchi S
Source :
American journal of ophthalmology [Am J Ophthalmol] 2016 Nov; Vol. 171, pp. 35-46. Date of Electronic Publication: 2016 Aug 24.
Publication Year :
2016

Abstract

Purpose: To assess the intraocular pressure (IOP)-lowering effects and safety of a carteolol/latanoprost fixed combination drug (OPC-1085EL) vs latanoprost (Study 1) and carteolol (Study 2) in patients with primary open-angle glaucoma (POAG) or ocular hypertension (OH).<br />Design: Multicenter, randomized, evaluator-masked (Study 1)/double-masked (Study 2), parallel-group studies.<br />Methods: Setting: Twenty-eight clinical sites (Study 1) and 19 clinical sites (Study 2) in Japan.<br />Study Population: Outpatients with bilateral POAG or OH whose predose IOP was 18 to <35 mm Hg in the study eye after 4 weeks' treatment with latanoprost (Study 1) or carteolol (Study 2) (defined as baseline).<br />Intervention: In Study 1, 237 patients applied OPC-1085EL (n = 118) or latanoprost (n = 119) for 8 weeks. In Study 2, 193 patients applied OPC-1085EL (n = 78), carteolol (n = 78), or carteolol/latanoprost concomitant therapy (n = 37) for 8 weeks.<br />Main Outcome Measure: Adjusted mean IOP reduction at predose from baseline to week 8.<br />Results: In Study 1, the adjusted mean IOP reductions (95% confidence interval [CI]) were 2.9 (2.5-3.3) mm Hg and 1.6 (1.2-2.0) mm Hg in the OPC-1085EL and latanoprost groups, respectively (P < .0001). In Study 2, the adjusted mean IOP reductions (95% CI) were 3.5 (3.1-3.9) mm Hg and 1.6 (1.2-2.0) mm Hg in the OPC-1085EL and carteolol groups, respectively (P < .0001). All adverse drug reactions of OPC-1085EL observed in both studies were mild in severity and only 1 patient in each study discontinued because of an adverse drug reaction.<br />Conclusions: OPC-1085EL is superior to latanoprost or carteolol alone in terms of lowering IOP, and was well tolerated.<br /> (Copyright © 2016 The Author(s). Published by Elsevier Inc. All rights reserved.)

Details

Language :
English
ISSN :
1879-1891
Volume :
171
Database :
MEDLINE
Journal :
American journal of ophthalmology
Publication Type :
Academic Journal
Accession number :
27565224
Full Text :
https://doi.org/10.1016/j.ajo.2016.08.022