article 學術新知
2022.03.03
「新產品」ACUVUE® Theravision® with Ketotifen 抗過敏隱形眼鏡(FDA:NDA 022388)(台灣未上市)

(點選圖片可下載FDA申請資料,若連結失效仍可至美國FDA網站查詢)

 

適應症與使用方式:

ACUVUE® Theravision™ with Ketotifen 是一種每日拋棄式的 etafilcon A 緩慢釋放藥物隱形眼鏡,用於預防過敏性結膜炎引起的眼部瘙癢、矯正無晶狀體和/或有晶狀體患者的屈光性屈光不正(近視和遠視) 眼睛、適合佩戴隱形眼鏡且散光不超過 1 D的情況。
鏡片含有 H1 組織胺受體拮抗劑,用於預防過敏性結膜炎引起的眼部瘙癢。 臨床試驗顯示,在鏡片配戴時的預防瘙癢效果可長達 12 小時。

 

INDICATIONS AND USAGE

ACUVUE® Theravision™ with Ketotifen is a daily wear, daily disposable etafilcon A drug-eluting contact lens for prevention ocular itch due to allergic conjunctivitis and correction of refractive ametropia (myopia and hyperopia) in aphakic and/or phakic patients who do not have red eye(s), are suitable for contact lens wear and do not have more than 1 D of astigmatism. The lens contains an H1 histamine receptor antagonist for the prevention of ocular itch due to allergic conjunctivitis. The prevention of itch has been demonstrated to last through 12 hours in clinical trials; however, the lens may be worn for longer than 12 hours in a single day.