title: Emedastine and allergic conjunctivitis: new preparation. Poor assessment.
abstract: (1) There is no clearly established reference eye-drop preparation for the treatment of allergic conjunctivitis. Steroid eye drops must be avoided. Virtually the only criterion on which to base the choice among the other antiallergic eye drops is the type and presence of preservatives, as these must be avoided by the small number of patients who are allergic to them. (2) In our opinion the clinical file on the 0.05% emedastine eye drops now available in France fails to answer many practical questions, as it almost solely comprises single-dose clinical pharmacology studies. (3) A trial involving 221 patients with allergic conjunctivitis, during a period of pollination, showed no tangible difference in efficacy between 0.05% emedastine and 0.05% levocabastine eye drops after 6 weeks of treatment. (4) The main adverse effects observed in clinical trials were local, consisting of eye redness, dryness and discomfort. When taken orally, emedastine is known to prolong the QT interval, and it is difficult to determine the precise cardiac risk during ocular administration. (5) 0.05% emedastine eye drops change nothing in the management of allergic conjunctivitis.
mesh_terms: D018926:Anti-Allergic Agents / Q000009:adverse effects / Q000627:therapeutic use; D001562:Benzimidazoles / Q000009:adverse effects / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D003233:Conjunctivitis, Allergic / Q000188:drug therapy*; D005602:France; D006634:Histamine H1 Antagonists / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D009883:Ophthalmic Solutions / Q000009:adverse effects / Q000627:therapeutic use; D010880:Piperidines / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D018926:Anti-Allergic Agents; D001562:Benzimidazoles; D006634:Histamine H1 Antagonists; D009883:Ophthalmic Solutions; D010880:Piperidines