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

Abstract

BackgroundThe 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.MethodsIn 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.ResultsMedian 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.ConclusionHydrocortisone 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 registrationCurrent Controlled Trials ISRCTN15464650.

Treatment of Non-Infectious Corneal Injury: Review of Diagnostic Agents, Therapeutic Medications, and Future Targets

“…As a single agent, data are limited regarding its efficacy in the ophthalmic literature. One study evaluating 411 patients with both hydrocortisone acetate 2.5% and hydrocortisone acetate 1% eye ointments reported that both formulations are efficacious and safe treatments for acute inflammation of the ocular surface or adnexa [ 38 ].…”