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J Tauber; Nedocromil Sodium 2% Ophthalmic Solution vs. Artificial Tears Used Twice Daily in Patients With Contact Lens Intolerance and a History of Allergic Conjunctivitis . Invest. Ophthalmol. Vis. Sci. 2002;43(13):116.
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Purpose:To evaluate the safety and efficacy of nedocromil 2% ophthalmic solution in patients with contact lens intolerance and a history of allergic conjunctivitis. Methods:A multicenter, randomized, investigator-masked, parallel group clinical trial. Patients (n=59) with a history of seasonal or perennial allergic conjunctivitis and disposable (≷ 1 day and ≤ 1 month) lens use for at least 30 days prior to study entry were randomized to receive nedocromil or artificial tears BID. Study visits were at baseline, week 1, and week 4. The primary outcome measures were change in contact lens wear time and physician evaluation of the overall effect of the study medications. Results:The mean contact lens wear time at the baseline evaluation was 6.4 hours in the nedocromil-treatment group and 6.5 hours in the tears group (P=.623). Both study medications produced a significant increase in daily contact lens wear time after 4 weeks of use (P≤.005). At the week 4 follow-up visit, the mean increase in daily contact lens wear time was 1.7 hours in the nedocromil group and 0.7 hours in the tears group (P=.026). Investigators noted at least 50% improvement in allergy symptoms in a significantly greater percentage of nedocromil patients (67.7%, 21/31) than in tears patients (35.7%, 10/28) after 4 weeks of study medications (P=.014). Conclusion:Both nedocromil and artificial tears extended the daily contact lens wearing time in patients with a history of lens intolerance and allergic conjunctivitis. However, the increase in daily contact lens wearing time provided by nedocromil was significantly greater than that provided by artificial tears after 4 weeks of treatment. These findings suggest that nedocromil may increase contact lens tolerability and prolong daily contact lens wearing time in patients who choose to wear contact lenses despite symptoms of ocular allergy.
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