title: 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: 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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN15464650.
authors.forename: Nikolay
authors.initials: N
authors.lastname: Sergiyenko
authors.forename: Ludmila
authors.initials: L
authors.lastname: Sukhina
authors.forename: Pavel
authors.initials: P
authors.lastname: Bezdetko
authors.forename: Yuriy
authors.initials: Y
authors.lastname: Kovalenko
authors.forename: Nikolai
authors.initials: N
authors.lastname: Nikitin
authors.forename: Matthias
authors.initials: M
authors.lastname: Merzbacher
authors.affiliation: URSAPHARM Arzneimittel GmbH, Saarbrücken, Germany. d.gross@ursapharm.de.
authors.forename: Dorothea
authors.initials: D
authors.lastname: Gross
authors.forename: Ralf
authors.initials: R
authors.lastname: Kohnen
mesh_terms: D000208:Acute Disease; D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage; D001762:Blepharitis / Q000175:diagnosis / Q000188:drug therapy*; D003228:Conjunctiva / Q000473:pathology*; D003315:Cornea / Q000473:pathology*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005143:Eyelids / Q000473:pathology*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006854:Hydrocortisone / Q000008:administration & dosage / Q000031:analogs & derivatives*; D007637:Keratoconjunctivitis / Q000175:diagnosis / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009824:Ointments; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000893:Anti-Inflammatory Agents; D009824:Ointments; C021650:hydrocortisone acetate; D006854:Hydrocortisone