Corneal penetration of timolol into the human aqueous humor after administration of 0.1% Timosan eye gel or 0.5% timolol eye drops

Santen Oy0 个研究点目标入组 44 人开始时间: 2006年3月30日最近更新: 2012年3月19日

适应症

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•Patients of any race and either sex meeting all of the following criteria will be considered eligible for this study. The patients should
•1.be 55-80 years
•2.be in good general health
•3.be scheduled for cataract surgery
•4.provide a written informed consent
•Are the trial subjects under 18?
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Patients with any of the following conditions are not eligible for participation in this study:
•1. patients with one sighted eye only
•2. patients who have glaucoma
•3. patients with previous surgical operation in the eye
•4. known hypersensitivity to timolol or any component of the study medication, including the preservative benzalkonium chloride
•5. use of any topical or systemic medication that could interfere with study medication
•6. any corneal disorders
•7. an active uveitis
•8. heart rate < 50/min
•9. contraindications to timolol treatment:
•– bronchial asthma / history of bronchospasm
•– history of bronchial asthma or severe obstructive pulmonary disease
•– sinus bradycardia
•– second or third degree AV block
•– overt cardiac failure
•– cardiogenic shock
•– severe peripheral circulatory disturbance (Raynaud’s disease) and
•peripheral disorders
•– Prinzmetal’s angina
•– untreated phaeochromocytoma
•– hypotension
•– corneal dystrophies
•– severe allergic rhinitis and bronchial hyperreactivity
•10. participation in another clinical trial involving an investigational drug/device, or participation in such trial within the last 30 days

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