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B.J. King, J. Tauber, ACOAT Study Group; Efficacy of Nedocromil Sodium 2% Ophthalmic Solution in Menopausal Women with Allergic Conjunctivitis: Results from a Community-based Trial . Invest. Ophthalmol. Vis. Sci. 2003;44(13):3725.
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Purpose: Menopausal women may be particularly susceptible to dry eye due to the effects of hormonal changes on the tear film and its stability. Menopausal women with allergic conjunctivitis (AC) are often given oral antihistamines, which can be drying. Non-drying topical therapies might be preferable for this patient population. We evaluated the efficacy and safety of topical nedocromil in menopausal women with ocular itch associated with AC. Methods: Subgroup analysis of a large, multicenter, 4-week, open-label, community-based trial. Eligible patients were ≥12 years old with active ocular itching and a history of perennial or seasonal AC. They instilled nedocromil sodium BID in each eye. Outcome measures included changes in signs, symptoms, quality of life variables, global improvement evaluations, and patient satisfaction. Of 1098 patients evaluated, 500 were women ≥45 years old. Subgroup analyses for these women are presented. Results: Of 500 menopause-aged women enrolled, 424 returned for the 1 month follow-up visit. The mean age in this group was 63.1 years. Patients reported significant improvements from baseline in itching, dryness, burning, watering, stinging, swelling, pain, and blurred vision (P<.001). There were significant reductions from baseline in bulbar conjunctival redness and swelling (P<.001). Physicians reported ≥75% improvement in the overall condition of 75% of patients (319/424). Further, there was a significant increase in patient satisfaction scores (P<.001), with 76% (320/424) reporting satisfaction with nedocromil. More than 76% of patients would use nedocromil again if prescribed. Nedocromil was safe and well tolerated, with only 10 patients (10/500, 2%) discontinuing due to an adverse event. Conclusions: Nedocromil improves signs and symptoms of AC in menopausal women, including symptoms of ocular irritation such as dryness, burning, and stinging. Nedocromil produces high levels of patient and physician satisfaction and significantly improves patient quality of life. These findings suggest that nedocromil is a good choice for the treatment of AC in menopausal women.
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