EUCTR2011-003692-12-PL进行中（未招募）不适用
A phase III , multicentre, randomised, investigator-masked, cross-over, comparative efficacy study of a generic Brinzolamide 10 mg/ml ophthalmic suspension (Azad Pharma AG) and Brinzolamide 10 mg/ml ophthalmic suspendion (Azopt®, Alcon) in open-angle glaucoma and ocular hypertension patients.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Ophthalmic inclusion criteria
- •1.Elevated IOP and open angles (irideocorneal angle >30 grad) in at least one eye: mean diurnal IOP measured at -12, -8, –4, -0 hours pre-treatment at Day 1 pre-treatment must be higher than 22 mmHg, and lower than or equal to 35 mmHg (untreated, i.e. after washout) in the study eye. If both eyes have the same IOP, the investigator will select the study eye, using a right, left assignment. Otherwise, the eye with higher IOP will be used for analysis.
- •2.Not on any ophthalmic pressure-lowering medication, or able to be withdrawn from current pressure-lowering medications for the washout periods as defined in this clinical trial protocol.
- •3.In the previous 3 months no ocular trauma, surgery, inflammation or infection, no corneal foreign body
- •4.No clinically significant or progressive retinal disease
- •5.No concomitant use of any topical ophthalmic medication other than artificial tears
- •6.No ocular glucocorticoids in the previous 3 months
- •7.No concomitant use of any medication that may increase adrenergic activity, i.e. psychotropes such as amitriptyline
- •8.No systemic medication that may alter IOP in the previous 30 days (e.g. beta-blockers, Ca-channel-blockers, ACE-inhibitors, prostaglandins, etc.), or expected to continue the current treatment with these medicinal products on a stable regimen for 30 days prior to the study and during the study.
- •9.Patients may be contact lens wearers but must remove their contact lenses prior to each drug application and keep out the lenses for a minimum of 15 minutes after drug application. In addition contact lenses must remain out for a minimum of 20 minutes when ocular discomfort assessments are required. Contact lenses cannot be worn on days of visits to the clinic.
- •Other inclusion criteria:
- •10.Age 18 years or older
- •11.Passing the screening examination
- •12.Giving written Informed Consent
- •13.General health conditions not interfering with participation in the study e.g. blood pressure, pulse rate at screening will be assessed by the investigator
- •14.Female patients of childbearing potential should be either sexually inactive (abstinent) for 60 days prior to the first dose and throughout the study or be using one of the following acceptable methods of birth control:
- •i.Surgically sterile (bilateral tubal ligation, hysterectomy, bilateral oophorectomy) 6 months minimum;
- •ii.IUD in place for at least 3 months;
- •iii.Barrier methods (condom, diaphragm) with spermicide for at least 60 days prior to the first dose and throughout the study;
- •iv.Hormonal contraceptives for at least 3 months prior to the first dose of the study
- •v.Postmenopausal women with amenorrhea for at least 2 years will be eligible
- •Are the trial subjects under 18? no
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •Ophthalmic exclusion criteria
- •1. Visual acuity of less than distance Snellen 20/100 corresponding to decimal 0.20 or 0.70 logMAR in either eye
- •2.Evidence of acute ocular infection, corneal foreign body, or ocular inflammation within 3 months of the screening visit
- •3.Previous significant ocular trauma, laser or incisional surgery within 3 months of the screening visit
- •4.IOP in either eye exceeding 35 mmHg (mean diurnal at Day 1: -12, -8, –4, -0 hours)
- •5.Any corneal abnormalities preventing reliable applanation tonometry
- •6.Clinical significant or progressive retinal disease or retinal detachement;as determined by dilated peripheral retinal examination done at screening.
- •7.Patients with risk of angle closure or evidence of acute, intermittent or chronic angle closure
- •8.Types of glaucoma other than POAG (primary open-angle glaucoma) such as pigmentary or pseudo-exfoliative glaucoma
- •9.Pupil with inadequate ability to dilate sufficiently for peripheral retinal examination
- •10.History or evidence of severe inflammatory eye disease (i.e. uveitis, retinitis, scleritis) in one or both eyes
- •11.Traumatic cataract surgery with an open posterior capsule or any patient with an anterior chamber intraocular lens implant or aphakia
- •Other exclusion criteria
- •12.Pregnant or nursing women and women of childbearing potential not using adequate contraception. An urine pregnancy test will be administered to women of childbearing potential during screening, during the Day 1 visits of both treatment periods, and again at the end of the study; if the patient has a positive urine pregnancy a serum ?-hCG test will be performed for confirmation of pregnancy.
- •13.Confirmed positive test for pregnancy at medical screening or prior to dosing of either period
- •14.Patients who have participated in another research study for an investigational drug within 60 days of the screening visit
- •15.History of drug or alcohol abuse within the last 6 months
- •16.A history of sensitivity to any component in the formulation of the products being tested
- •17.History of evidence of any medical condition that would, in the opinion of the investigator, make the patient unsuitable for the study (i.e. severe hepatic or renal impairment).
- •18.Patient with history of severe renal insufficiency (Creatinin Clearance <30ml/min) or hyperchloremic acidosis.
- •19.Hypertensivity to Brinzolamide and sulfonamides.
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