[Comparative clinical study of two dexamethasone phosphate-containing ophthalmics].
For the drug application of the already known active ingredient dexamethasone dihydrogen phosphate disodium salt (CAS 2392-39-4) for ocular use clinical data on the efficacy and safety were required by the drug regulatory agency. The comparison of the pharmaceutical properties had already shown that no differences in clinical use had to be expected. The results of a double-blind, randomised, comparative clinical study on 210 patients prove that no differences between test and comparator product could be observed. This case shows that the demand for clinical trials to proof therapeutic equivalence should be done with a sense of proportion related to the specific situation.
Gross
Dorothea
D
URSAPHARM Arzneimittel GmbH & Co. KG, Industriestrasse 35, 66129 Saarbrücken, Germany. d.gross@ursapharm.de
Struck
Hans-Gert
HG
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000627:therapeutic use*; D002387:Cataract Extraction; D002626:Chemistry, Pharmaceutical; D003907:Dexamethasone / Q000008:administration & dosage* / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D053685:Laser Therapy; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions / Q000008:administration & dosage* / Q000627:therapeutic use*; D013508:Ophthalmologic Surgical Procedures; D011183:Postoperative Complications / Q000517:prevention & control
D000893:Anti-Inflammatory Agents; D009883:Ophthalmic Solutions; D003907:Dexamethasone