title: [Safety and efficacy of a new preservative-free levocabastine ophthalmic solution (Levofree®) using the conjunctival provocation test].
abstract: OBJECTIVE
  To evaluate the safety and efficacy of preservative-free levocabastine 0.05 % ophthalmic solution compared to placebo (vehicle) and to preserved levocabastine 0.05 % ophthalmic suspension in the prevention of allergic conjunctivitis induced by a conjunctival provocation test.
  
  
  METHODS
  Ninety-two subjects (18-50 years) with a previous history of allergic conjunctivitis to pollen were randomised to receive either preservative-free levocabastine solution in one eye and preserved levocabastine suspension in the fellow eye (n=69), or preservative-free levocabastine in one eye and placebo in the fellow eye (n=23). One drop of each product was administered 10 minutes (visit 3) and 4 hours (visit 4) prior to the provocation test. The primary efficacy criterion was the sum of the itching and conjunctival hyperemia scores assessed at 3, 5 and 10 minutes after the provocation test. The safety evaluation included adverse events, visual acuity, intra-ocular pressure and study drug drop sensation.
  
  
  RESULTS
  The efficacy of the preservative-free solution was significantly higher than that of placebo at all time points (P≤0.01) with one exception at visit 4 (3 minutes after the provocation test). It was significantly higher than that of the preserved suspension at visit 3, and equivalent at visit 4. The incidence of adverse events was lower with the preservative-free solution than with the preserved suspension. 94.2 % and 95.7 % subjects rated preservative-free levocabastine drop sensation as "good" or "very good" at visits 3 and 4 respectively, whereas these rates were 68.1 % and 63.8 % with preserved levocabastine. This difference between the two formulations was highly statistically significant (P<0.001).
  
  
  CONCLUSIONS
  The efficacy of preservative-free levocabastine was superior to that of the placebo and of the preserved suspension at visit 3, at least as effective as the preserved suspension at visit 4, and better tolerated at each visit.
authors.affiliation: Bausch+Lomb, Laboratoire Chauvin SA, 416, rue Samuel-Morse, CS 99535, 34961 Montpellier cedex 2, France.
authors.forename: C
authors.initials: C
authors.lastname: Allaire
authors.forename: R
authors.initials: R
authors.lastname: Siou-Mermet
authors.forename: A
authors.initials: A
authors.lastname: Bassols
mesh_terms: D060433:Administration, Ophthalmic; D000293:Adolescent; D000328:Adult; D000485:Allergens; D002626:Chemistry, Pharmaceutical / Q000379:methods; D003228:Conjunctiva / Q000276:immunology; D003233:Conjunctivitis, Allergic / Q000175:diagnosis* / Q000188:drug therapy* / Q000473:pathology; D003941:Diagnostic Techniques, Ophthalmological; D005260:Female; D039563:Histamine H1 Antagonists, Non-Sedating / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology; D006801:Humans; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology; D010880:Piperidines / Q000008:administration & dosage* / Q000009:adverse effects* / Q000494:pharmacology; D011310:Preservatives, Pharmaceutical; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000485:Allergens; D039563:Histamine H1 Antagonists, Non-Sedating; D009883:Ophthalmic Solutions; D010880:Piperidines; D011310:Preservatives, Pharmaceutical; C047340:levocabastine