Efficacy and safety of ketotifen eye drops in the treatment of seasonal allergic conjunctivitis

Kidd, M., McKenzie, S.H., Steven, I., Cooper, C., Lanz, R., and Australian Ketotifen Study Group, (2003) Efficacy and safety of ketotifen eye drops in the treatment of seasonal allergic conjunctivitis. British Journal of Ophthalmology, 87 (10). pp. 1206-1211.

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Background: Ketotifen blocks histamine H1 receptors, stabilises mast cells, and prevents eosinophil accumulation. These multiple, pharmacological mechanisms provided the rationale for assessing the efficacy and safety of ketotifen 0.025% eye drops in subjects with seasonal allergic conjunctivitis (SAC) in an environmental setting.

Methods: This was a double masked, randomised, multicentre trial conducted in Australia. Subjects were randomly assigned to ketotifen fumarate 0.025% ophthalmic solution, placebo (as vehicle), or levocabastine hydrochloride 0.05% ophthalmic suspension, twice daily in each eye for a 4 week period. Subjects were assessed at follow up (days 5–8) and termination (days 25–31) visits. The primary efficacy variable was the responder rate, based on the subjects’ assessment of global efficacy at the follow up visit.

Results: 519 subjects were randomised to treatment. At the follow up visit, the responder rate, based on subjects’ assessment of global efficacy, was significantly greater in the ketotifen group (49.5%) than in the placebo group (33.0%) for subjects with a positive diagnostic test for pollen allergy (p = 0.02). The investigators’ assessment of responder rates also showed that ketotifen was superior to placebo (p = 0.001). Ketotifen produced a significantly better outcome than levocabastine (p,0.05) for relief of signs and symptoms of SAC, at both the follow up and the termination visit. The type and frequency of adverse events were similar across treatment groups.

Conclusions: In an environmental setting, ketotifen fumarate 0.025% ophthalmic solution was well tolerated and effective in reducing the signs and symptoms of SAC, and in preventing their recurrence. Ketotifen consistently showed the best efficacy in comparison with both placebo and levocabastine. These results indicate that ketotifen eye drops are a valuable treatment option for this condition.

Item ID: 18410
Item Type: Article (Research - C1)
ISSN: 1468-2079
Keywords: allergic conjunctivitis, ketotifen, levocabastine
Funders: Novartis Ophthalmics AG
Date Deposited: 12 Jun 2012 05:34
FoR Codes: 11 MEDICAL AND HEALTH SCIENCES > 1117 Public Health and Health Services > 111717 Primary Health Care @ 50%
11 MEDICAL AND HEALTH SCIENCES > 1115 Pharmacology and Pharmaceutical Sciences > 111502 Clinical Pharmacology and Therapeutics @ 50%
SEO Codes: 92 HEALTH > 9201 Clinical Health (Organs, Diseases and Abnormal Conditions) > 920107 Hearing, Vision, Speech and Their Disorders @ 100%
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