Safety of Unoprostone Isopropyl 0.15% Ophthalmic Solution in Patients with Mild to Moderate Asthma

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Abstract

Purpose: To assess the safety of unoprostone isopropyl 0.15% ophthalmic solution (UIOS) in patients with mild to moderate asthma. Methods: Randomized, double-masked, two-period crossover, placebo-controlled study comparing unoprostone 0.15% with vehicle-placebo. Pulmonary function tests conducted at baseline and during the 4-hour postdose observation period included forced expiratory volume in 1 s, forced vital capacity, peak expiratory flow rate, and bronchodilator response after 200 µg inhaled salbutamol. Results: There were no significant changes in pulmonary function up to 4 h postdose after treatment with 1 drop unoprostone 0.15% in each eye. Conclusion: Unoprostone 0.15% was safe for use in patients with mild to moderate asthma, without affecting the response to bronchodilator therapy.

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A double-masked randomized comparison of the efficacy and safety of unoprostone with timolol and betaxolol in patients with primary open-angle glaucoma including pseudoexfoliation glaucoma or ocular hypertension. 6 month data11Financial disclosure: This study was sponsored by Novartis Ophthalmics, Inc., the distributor of unoprostone isopropyl (Rescula®) in Europe and the U.S. Dr. Nordmann is a consultant for Novartis Ophthalmics, Inc. The investigators received compensation for conducting the study, but have no proprietary or stock interest in Novartis Ophthalmics, Inc.

Jean-Philippe Nordmann, Beat Mertz, Natalia C Yannoulis … (2002)

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Author and article information

Journal

Journal ID (publisher-id): OPH

Journal ID (nlm-ta): Ophthalmologica

Journal ID (doi): 10.1159/issn.0030-3755

Title: Ophthalmologica

Publisher: S. Karger AG

ISSN (Print): 0030-3755

ISSN (Electronic): 1423-0267

Publication date Subscription-year: 2003

Publication date (Print): April 2003

Publication date (Electronic): 27 February 2003

Volume: 217

Issue: 2

Pages: 129-136

Affiliations

^aChiltern, Slough, UK; ^bNovartis Ophthalmics AG, Bülach, Switzerland; ^cNovartis Ophthalmics, Inc., Duluth, Ga., USA

Article

Publisher ID: 68558 Other ID: Ophthalmologica 2003;217:129–136

DOI: 10.1159/000068558

PubMed ID: 12592052

SO-VID: 4d959a97-f326-4142-b119-aa1138865d4a

License:

Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher. Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug. Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.

History

Date received : 08 February 2002

Date accepted : 29 July 2002

Page count

Figures: 2, Tables: 4, References: 32, Pages: 8

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