Non-inferiority evaluation of preservative-free latanoprost/timolol eye drops solution versus preserved latanoprost/timolol eye drops in patients with high intraocular pressure and open-angle glaucoma
- سال انتشار: 1399
- محل انتشار: مجله نظریه پردازی در چشم پزشکی، دوره: 9، شماره: 4
- کد COI اختصاصی: JR_MEOP-9-4_004
- زبان مقاله: انگلیسی
- تعداد مشاهده: 91
نویسندگان
چکیده
Abstract Background: This study aimed to evaluate the non-inferiority and safety of a newly developed preservative-free (PF) multi-dose latanoprost/timolol ophthalmic solution, compared with the benzalkonium chloride (BAK)-preserved fixed combination, in patients with open-angle glaucoma and ocular hypertension. Methods: A Phase III randomized multi-center observer-blind parallel-group clinical trial was conducted. A total of ۲۱۰ adult patients (aged over ۱۸ years) were randomly treated with the PF- or the BAK-preserved latanoprost/timolol solution once daily in the affected eye(s) for ۱۲ weeks. Follow-up visits were scheduled at weeks ۲, ۶, and ۱۲; intraocular pressure (IOP) was recorded at ۸:۰۰ AM, ۱۲:۰۰ PM, and ۴:۰۰ PM. The primary efficacy endpoint to prove non-inferiority was the IOP change at ۸:۰۰ AM (± ۱ hour) from the baseline to the end of treatment (week ۱۲) in the studied eye. Safety parameters were also assessed. Results: In total, ۱۹۶ patients completed the study. The pressure-lowering effect of the PF eye drops was comparable to that of the preserved formulation at all time points. Latanoprost/timolol PF formulation was non-inferior to the BAK-preserved solution as shown by the change in IOP from day ۰ to week ۱۲. The point estimate of the inter-treatment difference was ۰.۶۲۴ mmHg (۹۵% CI: -۰.۰۹۴, ۱.۳۴۱). Both treatments were well-tolerated during the study, and they had similar adverse event profiles. Conclusions: PF-latanoprost/timolol combination was found to be non-inferior to the BAK-preserved formulation based on the efficacy at all times, with similar local tolerance.کلیدواژه ها
اطلاعات بیشتر در مورد COI
COI مخفف عبارت CIVILICA Object Identifier به معنی شناسه سیویلیکا برای اسناد است. COI کدی است که مطابق محل انتشار، به مقالات کنفرانسها و ژورنالهای داخل کشور به هنگام نمایه سازی بر روی پایگاه استنادی سیویلیکا اختصاص می یابد.
کد COI به مفهوم کد ملی اسناد نمایه شده در سیویلیکا است و کدی یکتا و ثابت است و به همین دلیل همواره قابلیت استناد و پیگیری دارد.