Pemirolast potassium 0.1% ophthalmic solution is an effective treatment for allergic conjunctivitis: A pooled analysis of two prospective, randomized, double-masked, placebo-controlled, phase III studies

被引:28
作者
Abelson, MB [1 ]
Berdy, GJ [1 ]
Mundorf, T [1 ]
Amdahl, LD [1 ]
Graves, AL [1 ]
机构
[1] Harvard Univ, Sch Med, Schepens Eye Res Inst, Boston, MA 02115 USA
关键词
D O I
10.1089/10807680260362759
中图分类号
R77 [眼科学];
学科分类号
100212 ;
摘要
Patients with allergic conjunctivitis may experience several debilitating symptoms, particularly ocular itching. The objective of this study was to evaluate the efficacy and safety of pemirolast potassium 0.1% ophthalmic solution (Alamast(TM)), a novel mast-cell stabilizer, for preventing ocular manifestations of seasonal allergic conjunctivitis. A pooled analysis was performed of data derived from 2 prospective, randomized, double-masked, placebo-controlled, multicenter phase III clinical trials of pemirolast potassium 0.1% in patients with a history of allergic conjunctivitis. Patients having a positive bilateral response to conjunctival allergen challenge (CAC) with ragweed antigen (N = 274) were randomized to receive pemirolast potassium 0.1% or placebo QID, beginning approximately 1-2 weeks before the onset of ragweed season and continuing until after the first killing frost (12-17 weeks duration). Patients recorded their daily evaluations of ocular itching in a diary. After the allergy season, patients underwent a second CAC. Evaluable patients (n = 265) recorded a total of 21,491 patient-days of ocular itching data during allergy season. In every 7-day or 14-day period, patients treated with pemirolast potassium 0.1% reported more days without any ocular itching compared with patients receiving placebo. Differences favoring pemirolast potassium 0.1% were statistically significant in 63% (10/16) of all 7-day periods (p less than or equal to 0.046) and 88% (7/8) of all 14-day periods (p less than or equal to 0.016). After the allergy season, pemirolast potassium 0.1% was significantly superior to placebo in relieving CAC-induced ocular itching, with relief occurring as early as 3 minutes after allergen challenge (p less than or equal to 0.034). Pemirolast potassium 0.1% was well tolerated and had a safety profile similar to that of placebo. In conclusion, pemirolast potassium 0.1% is effective and safe in preventing ocular itching in patients with allergic conjunctivitis during allergy season.
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页码:475 / 488
页数:14
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