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
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
BMC Ophthalmology 2014, 14:64 doi:10.1186/1471-2415-14-64Published: 10 May 2014
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.
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.
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.
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.
Current Controlled Trials ISRCTN15464650.