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P. Gous, A. Ropo; A Comparison of the Safety and Efficacy of 0.1% Pemirolast Potassium Ophthalmic Solution Dosed Twice Daily (BID) versus Four Times Daily (QID) in Patients with Seasonal Allergic Conjunctivitis (SAC) . Invest. Ophthalmol. Vis. Sci. 2003;44(13):3732.
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© ARVO (1962-2015); The Authors (2016-present)
Purpose: To demonstrate that BID dosing of 0.1% pemirolast potassium ophthalmic solution is similar to QID in SAC patients. Methods: An investigator-masked, randomized, parallel group trial was conducted in 169 patients at 10 centers in South Africa. Patients, ages 6 years or older, with a positive skin prick test and active SAC (+2 itching and hyperemia), were randomized to receive BID or QID treatment during allergy season. Visits occurred at 0, 2, and 4 weeks. Investigators assessed itching and hyperemia, the primary endpoints, using 0-4 scales. Patients reported daily symptom scores in diaries. ITT and PP data were analyzed using LOCF. ANOVA tests were used for week 4 itching (average of both eyes) and hyperemia (worse eye), factoring in treatment and center. A 95% CI with an upper limit of <0.5 was set to assess non-inferiority of the BID regimen against the QID regimen. Results: In the ITT population, baseline severity was moderate to severe in the BID and QID groups respectively for itching (2.6 and 2.8) and hyperemia (2.3 and 2.2). Both produced considerable reductions in itching at week 4 (BID: –1.6 and QID: -2.0). The mean treatment difference between groups for itching was 0.17 with a 95% CI of (-0.13, 0.47), Δ<0.5. The mean reduction for hyperemia at week 4 was -1.1 for BID vs.-1.2 for QID dosing. The mean treatment difference for hyperemia was 0.27, with a 95% CI of (0.01, 0.52). Investigators overall efficacy assessment was similar, 90% for BID vs. 93% for QID. Patient diary data supported non-inferiority. Both regimens were similarly well tolerated and there were no notable differences between the two in safety. Conclusions: BID dosing of 0.1% pemirolast was statistically equivalent to QID dosing in reducing itching in patients with active SAC. Both dosing regimens were well tolerated.
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