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J Fr Ophtalmol. 2014 Jan;37(1):1-8. doi: 10.1016/j.jfo.2013.02.007. Epub 2013 Dec 31.

Comparison of preservative-free ketotifen fumarate and preserved olopatadine hydrochloride eye drops in the treatment of moderate to severe seasonal allergic conjunctivitis.

Author information

  • 1Service d'ophtalmologie, hôpital Pontchaillou, CHU de Rennes, 2, rue Henri-Le-Guilloux, 35033 Rennes cedex 9, France. Electronic address:
  • 2Service d'ophtalmologie, nouvel hôpital civil, 1, place de l'Hôpital, 67091 Strasbourg, France.
  • 3Service d'ophtalmologie, CHU Fattouma Bourguiba, rue du 1er-juin-1955, 5000 Monastir, Tunisia.
  • 4Service d'ophtalmologie, CHU Tahar Sfar, 5000 Mahdia, Tunisia.
  • 5Laboratoire de toxicologie, faculté des sciences pharmaceutiques et biologiques, 4, avenue de l'Observatoire, 75006 Paris, France.
  • 6Laboratoires THEA, 12, rue Louis-Blériot, 63000 Clermont-Ferrand, France.
  • 7Service d'ophtalmologie, centre Saint-Victor, CHU d'Amiens, 354, boulevard de Beauvillé, 80054 Amiens cedex, France.



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.


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).


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).


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.

Copyright © 2013. Published by Elsevier Masson SAS.


Conjonctivite allergique saisonnière; Conservateur; ICAM-1; Ketotifen; Kétotifène; Olopatadine; Preservative; Seasonal allergic conjunctivitis

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