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L. Krokhmal, P. Gomes, D. Welch, M. B. Abelson; The Incidence of Dry Eye With Topical Anti-Allergic Therapies. Invest. Ophthalmol. Vis. Sci. 2007;48(13):2300.
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Systemic antihistamines are known to cause ocular dryness, which is attributed to their M3 anticholinergic effects. To establish whether or not ocular dryness occurs with topical anti-allergic treatments, a retrospective analysis was performed on clinical trial data of the dual action antihistamine/mast cell stabilizers. The incidence of ocular drying was recorded and compared.
Published literature and regulatory documentation were reviewed to determine the incidence of dry eye for olopatadine 0.1% (Alcon), olopatadine 0.2% (Alcon), ketotifen 0.25% (Novartis), azelastine 0.05% (MedPointe), and epinastine 0.05% (Allergan/Inspire). The analysis included studies lasting 2 to 6 weeks that compared these anti-allergic treatments to placebo
In the olopatadine 0.1% trial, incidence of dry eye was 1/189 (0.5%) for the active group and 1/96 for the placebo group (1.0%). In a second olopatadine 0.1% study, the incidence of dry eye was 1/244 (0.4%) for the active group and 1/125 (0.8%) for the placebo group. In an analysis of trial results for olopatadine 0.2%, the incidence of dry eye was 3/638 (0.5%) for the active groups and 2/523 (0.4%) for the placebo groups. In the ketotifen 0.25% trial, dry eyes occurred in 15/330 (4.5%) in the active group, compared to 7/165 (4.2%) in the placebo group. In the azelastine trial, there were no reports of dry eye. In the epinastine 0.05% trial, the incidence of eye dryness in the epinastine group was 1/158 (0.6%) compared to 1/228 (0.4%) for the placebo group.
This analysis, involving 2696 subjects, demonstrated that the incidence of dry eye following repeated dosing with 5 topical anti-allergic treatments was less than or equal to that of placebo. These data support our clinical implication that topical, unlike systemic, anti-allergic products do not produce ocular surface drying, as reported in clinical trials.
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