Hydrocortisone concentration influences time to clinically significant healing of acute inflammation of the ocular surface and adnexa – results from a double-blind randomized controlled trial

Language
en
Document Type
Article
Issue Date
2014-09-16
Issue Year
2014
Authors
Sergiyenko, Nikolay
Sukhina, Ludmila
Bezdetko, Pavel
Kovalenko, Yuriy
Nikitin, Nikolai
Merzberger, Matthias
Groß, Dorothea
Kohnen, Ralf
Editor
Abstract

Background The efficacy of topical ophthalmic corticosteroids depends upon small modifications in preparations, such as drug concentration. The aim of this study was to confirm that hydrocortisone acetate (HC-ac) ophthalmic ointments of 2.5% and 1% are more effective than a 0.5% eye ointment. Methods In this randomized, double-blind, placebo-controlled, parallel-group clinical study, the change of signs and symptoms of acute inflammation of the ocular surface and adnexa was evaluated in 411 subjects. Results Median time to clinically relevant response as estimated by 50% reduction in clinical signs and symptoms (CSS) total score over the entire trial was similar for subjects treated with HC-ac 2.5% (73.5 h) and for subjects treated with HC-ac 1.0% (67.7 h) and was considerably and significantly longer for subjects treated with HC-ac 0.5% (111.8 h) [p < 0.001 for both dosages]. All trial medications were safe and well tolerated. Conclusion Hydrocortisone acetate 2.5% and Hydrocortisone acetate 1% eye ointments are efficacious and safe treatments for acute inflammations of the ocular surface or adnexa, and showed significantly better efficacy than a control group treated with Hydrocortisone acetate 0.5% therapy.

Journal Title
BMC Ophthalmology
Volume
14
Citation
BMC Ophthalmology 14 (2014): S. 64 - 72. <http://www.biomedcentral.com/1471-2415/14/64>
DOI
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