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M. Alexander, M. Plumley; Efficacy of Nedocromil Sodium 2% Ophthalmic Solution Used Twice-daily versus Once-daily in Pediatric Patients with Allergic Conjunctivitis . Invest. Ophthalmol. Vis. Sci. 2003;44(13):3726.
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© ARVO (1962-2015); The Authors (2016-present)
Purpose: To evaluate the efficacy of nedocromil sodium 2% BID or QD in controlling symptoms of allergic conjunctivitis (AC) in pediatric patients. Methods: Randomized, investigator-masked, single-center crossover study. Study visits were at Days 0 and 6 and Weeks 3 and 5. Patients 3-17 years of age (n=38) with symptoms of ragweed pollen AC or their caregivers were instructed to instill nedocromil into both eyes BID for 5 days. On Day 6, patients were randomly assigned to continue nedocromil BID or to reduce dosing to QD for 2 weeks. Patients then crossed over to the other dosing regimen. Signs and symptoms were evaluated. The Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) for pediatrics was administered at each visit. Patients recorded their allergic symptoms daily. Results: The mean age of the study population was 11.1 years. Nedocromil, when used either QD or BID, provided statistically significant reductions in mean symptom scores for itching, watering, and ocular soreness (P≤.018), with no differences between regimens (P≥.442). With both regimens, patients reported significant improvements in ability to participate in outdoor activities and in the frequency of rubbing the nose and eyes (P<.001). There were no significant differences between dosing regimens in any quality of life measure or symptoms evaluated by the RQLQ (P≥.062). Both regimens significantly reduced erythema, edema, conjunctival injection, and conjunctival symptoms compared with Day 0 (P≤.003), with no statistically significant differences between dosing regimens (P≥.374). There were no significant between-group differences in mean patient diary scores. There were no clinically significant adverse events, nor any withdrawals due to AEs. Conclusions: Nedocromil effectively improves signs and symptoms associated with AC in pediatric patients. In the present study, nedocromil was used BID to establish initial control of allergic signs and symptoms. This control was maintained after the switch to QD dosing. These findings demonstrate that nedocromil is a potent medication for the long-term control of ocular allergy symptoms in pediatric patients.
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