title: Comparison of preservative-free ketotifen fumarate and preserved olopatadine hydrochloride eye drops in the treatment of moderate to severe seasonal allergic conjunctivitis.
abstract: OBJECTIVE
  To compare preservative-free ketotifen 0.025% ophthalmic solution to olopatadine 0.1% ophthalmic solution in with the treatment of seasonal allergic conjunctivitis (SAC) in clinical practice.
  
  
  METHODS
  This was a comparative, randomised, investigator-masked, pilot clinical study in adult patients with documented history of SAC and presenting with moderate to severe itching and conjunctival hyperemia. Eligible patients initiated either ketotifen or olopatadine treatment at a dose of one drop twice daily for 28days. The resolution of ocular signs and symptoms was assessed on day 7 and day 28. Itching was also assessed within 15minutes following the first instillation (day 0). Conjunctival impression cytology was performed at each visit to assess the evolution of ICAM-1 expression (day 0, 7 and 28).
  
  
  RESULTS
  Seventy-five patients were randomised (ketotifen: 38 patients; olopatadine: 37 patients). At day 28, the composite score for primary criteria (itching, tearing, and conjunctival hyperemia) improved from 6.8±1.2 to 0.9±1.0 in the Ketotifen group, without statistically significant difference between treatment groups (P=0.67). There was no relevant difference between treatment groups in other efficacy parameters, except a trend for a more rapid resolution of conjunctival hyperemia in the Ketotifen group. Both drugs were well tolerated, with a trend for a better tolerability reported by patients on ketotifen compared to those on olopatadine at day 7 (P=0.054).
  
  
  CONCLUSIONS
  A rapid and comparable improvement in SAC was achieved after 28days of treatment with both preservative-free ketotifen and preserved olopatadine ophthalmic solutions, with a slightly better ocular tolerance with unpreserved ketotifen 0.025% eye drops.
authors.affiliation: Service d'ophtalmologie, hôpital Pontchaillou, CHU de Rennes, 2, rue Henri-Le-Guilloux, 35033 Rennes cedex 9, France. Electronic address: Bruno.MORTEMOUSQUE@chu-rennes.fr.
authors.forename: B
authors.initials: B
authors.lastname: Mortemousque
authors.affiliation: Service d'ophtalmologie, nouvel hôpital civil, 1, place de l'Hôpital, 67091 Strasbourg, France.
authors.forename: T
authors.initials: T
authors.lastname: Bourcier
authors.affiliation: Service d'ophtalmologie, CHU Fattouma Bourguiba, rue du 1er-juin-1955, 5000 Monastir, Tunisia.
authors.forename: M
authors.initials: M
authors.lastname: Khairallah
authors.affiliation: Service d'ophtalmologie, CHU Tahar Sfar, 5000 Mahdia, Tunisia.
authors.forename: R
authors.initials: R
authors.lastname: Messaoud
authors.affiliation: Laboratoire de toxicologie, faculté des sciences pharmaceutiques et biologiques, 4, avenue de l'Observatoire, 75006 Paris, France.
authors.forename: F
authors.initials: F
authors.lastname: Brignole-Baudouin
authors.affiliation: Laboratoires THEA, 12, rue Louis-Blériot, 63000 Clermont-Ferrand, France.
authors.forename: D
authors.initials: D
authors.lastname: Renault
authors.affiliation: Laboratoires THEA, 12, rue Louis-Blériot, 63000 Clermont-Ferrand, France.
authors.forename: H
authors.initials: H
authors.lastname: Rebika
authors.affiliation: Service d'ophtalmologie, centre Saint-Victor, CHU d'Amiens, 354, boulevard de Beauvillé, 80054 Amiens cedex, France.
authors.forename: D
authors.initials: D
authors.lastname: Brémond-Gignac
mesh_terms: D000328:Adult; D000368:Aged; D018926:Anti-Allergic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D003233:Conjunctivitis, Allergic / Q000188:drug therapy*; D003990:Dibenzoxepins / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D007665:Ketotifen / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D000069605:Olopatadine Hydrochloride; D009883:Ophthalmic Solutions; D010865:Pilot Projects; D011310:Preservatives, Pharmaceutical / Q000008:administration & dosage* / Q000009:adverse effects; D012621:Seasons; D012720:Severity of Illness Index; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D018926:Anti-Allergic Agents; D003990:Dibenzoxepins; D009883:Ophthalmic Solutions; D011310:Preservatives, Pharmaceutical; C514418:ketotifen fumarate ophthalmic solution; D000069605:Olopatadine Hydrochloride; D007665:Ketotifen
keywords: Conjonctivite allergique saisonnière; Conservateur; ICAM-1; Ketotifen; Kétotifène; Olopatadine; Preservative; Seasonal allergic conjunctivitis