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G. Torkildsen, M.B. Abelson; Comparison of Topical and Systemic Anti–Allergy Treatments Relative to Ocular Dryness . Invest. Ophthalmol. Vis. Sci. 2006;47(13):4976.
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A common side effect of systemic antihistamines is ocular dryness. This effect is attributed to their M3 anticholinergic systemic effect. We wished to determine by retrospective analysis of pivotal trial data whether topical anti–allergy treatments also cause ocular drying.
We reviewed the literature and compared the incidence of dry eye for the 3 most widely prescribed topical anti–allergy treatments compared to placebo in clinical trials lasting 2 to 6 weeks. We also reviewed the results of trials involving loratadine and cetirizine HCl relative to signs and symptoms of dry eye (decreased tear film break–up times, increased conjunctival staining, and increased ocular discomfort scores).
In the epinastine HCl 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. In the ketotifen 0.25% trial, dry eyes occurred for 15/330 (4.5%) in the active group, compared to 7/165 (4.2%) in the placebo group. In the olopatadine 0.1% trial, incidence of dry eye was 1/189 (0.5%) for the active and 1/96 for the placebo group (1.0%). In a second olopatadine study, the incidence of dry eyes was 1/267 (0.4%) for the active group and 1/138 (0.7%) for the placebo group. Looking at systemic antihistamines compared to baseline in normal patients, use of loratadine led to a mean increase of 0.75 points (107%) in keratitis, a mean increase of 1.35 points (133%) in conjunctival staining, a mean decrease of 1.38 seconds (33.7%) in TFBUT, and a mean increase of 0.32 points (24.8%) in ocular discomfort. Compared to baseline, after using cetirizine HCl for 4 days, there was a mean increase of 0.57 points (60%) in keratitis, a mean increase of 0.7 points (49.7%) in conjunctival staining, and a mean decrease of 0.76 seconds (19.6%) in TFBUT (P =0.05).
The incidence of dry eye following repeated dosing with 3 different topical anti–allergy treatments is less than or equal to that of placebo. Systemic antihistamines cause signs and symptoms of dry eye to worsen. Ketotifen, epinastine, and olopatadine have not been shown to have any muscarinic activity. Focused therapy with topical anti–allergy is clearly superior to systemic antihistamines with regard to ocular dryness.
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