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Open Access Research article

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

Nikolay Sergiyenko1, Ludmila Sukhina2, Pavel Bezdetko3, Yuriy Kovalenko4, Nikolai Nikitin5, Matthias Merzbacher6, Dorothea Groß7* and Ralf Kohnen89

Author Affiliations

1 Kiev City Ophthalmological Hospital, Kiev, Kharkov, Ukraine

2 Donetsk City Clinical Hospital, Donetsk, Ukraine

3 Department of Ophthalmology, Kharkov District Clinical Hospital, Kharkov, Ukraine

4 C Girshman Clinical City Hospital, Kharkov, Ukraine

5 RUSSLAN Clinical Research Ltd, North Humberside, UK

6 RPS Research Germany GmbH, Nuremberg, Germany

7 URSAPHARM Arzneimittel GmbH, Saarbrücken, Germany

8 ReSearch Pharmaceutical Services, Inc, Fort Washington, PA, USA

9 Psychology Department, University of Erlangen-Nuremberg, Nuremberg, Germany

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BMC Ophthalmology 2014, 14:64  doi:10.1186/1471-2415-14-64

Published: 10 May 2014

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.

Trial registration

Current Controlled Trials ISRCTN15464650.

Keywords:
Ophthalmic corticosteroids; Hydrocortisone acetate; Ocular surface; Adnexa; Acute inflammation; Clinical study; Eye ointment; Adaptive design; Treatment outcome