Original Paper

Safety of Unoprostone Isopropyl 0.15% Ophthalmic Solution in Patients with Mild to Moderate Asthma
Kulasiri A. Gunawardena^a, Nathan Crame^a, Beat Mertz^b, Naveed Shams<sup>c

a</sup>Chiltern, Slough, UK;
^bNovartis Ophthalmics AG, Bülach, Switzerland;
^cNovartis Ophthalmics, Inc., Duluth, Ga., USA

Address of Corresponding Author

Ophthalmologica 2003;217:129-136 (DOI: 10.1159/000068558)

  Key Words

• Unoprostone
• Docosanoid
• Asthma
• Glaucoma
• Bronchodilator

  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.

Copyright © 2003 S. Karger AG, Basel

  Author Contacts

Naveed Shams, MD, PhD
Director, Clinical Science
Clinical R&D - Americas Novartis Ophthalmics, Inc.
11695 Johns Creek Parkway, Duluth, GA 30097 (USA)
Tel. +1 770 905 1868, Fax +1 770 905 1268, E-Mail naveed.shams@pharma.novartis.com

  Article Information

Supported by Novartis Ophthalmics, AG (formerly CIBA Vision AG).Dr. Mertz and Dr. Shams are employees of Novartis Ophthalmics, the manufacturer of unoprostone isopropyl 0.15% ophthalmic solution. The other authors have no proprietary interest in unoprostone isopropyl.

Received: February 8, 2002
Accepted after revision: July 29, 2002
Number of Figures : 2, Number of Tables : 4, Number of References : 32