EUCTR2021-003387-27-HU进行中（未招募）1 期
A PHASE III, MULTICENTRE, RANDOMISED, INVESTIGATOR-MASKED, CROSS-OVER, COMPARATIVE, NON-INFERIORITY TRIAL OF GENERIC LATANOPROST + TIMOLOL (50µG + 5MG)/ML EYE DROPS, SOLUTION (POLPHARMA S.A.) COMPARED TO XALACOM® (LATANOPROST 0.005 % OPHTHALMIC SOLUTION & TIMOLOL 0.5% FIXED COMBINATION, PFIZER) IN PATIENTS WITH OCULAR HYPERTENSION OR PRIMARY OPEN ANGLE GLAUCOMA.
Pharmaceutical Works Polpharma S.A. (Polpharma S. A.)0 个研究点目标入组 40 人开始时间: 2021年9月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
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
- •INCLUSION CRITERIA
- •Ocular hypertension or primary open angle glaucoma in at least one eye: mean diurnal IOP measured on Day 1 before treatment at 8 am, 12 pm and 4 pm on the day must be higher than or equal to 22 mmHg, and lower than or equal to 34 mmHg (untreated, i.e. after washout).
- •Not on any ophthalmic pressure-lowering medication, or able to be withdrawn from current pressure-lowering medications for the washout periods as defined in this clinical trial protocol.
- •No clinically significant or progressive retinal disease.
- •No concomitant use of any topical ophthalmic medication other than artificial tears
- •No ocular glucocorticoids in the previous 3 months
- •No concomitant use of any medication that may increase adrenergic activity, i.e. psychotropic substances such as amitriptyline
- •No systemic medication that may alter IOP in the previous 30 days (e.g. beta blockers, calcium channel blockers, ACE inhibitors, prostaglandins, etc.) or expected to continue the current treatment with these medicinal products on a stable regimen for the duration of the study.
- •Other inclusion criteria
- •Age: 18-85 years old
- •Provision of signed and dated Informed Consent.
- •General health conditions not interfering with participation in the study determined e.g. by blood pressure, pulse rate and temperature at screening as assessed by the Investigator
- •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 acceptable methods of birth control.
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Exclusion Criteria
- •Corrected visual acuity of less than 20/100 in both eyes
- •Evidence of acute ocular infection, corneal foreign body, or ocular inflammation within 3 months of the screening visit.
- •History or evidence of severe inflammatory eye disease (i.e. uveitis, retinitis, scleritis, iritis) in one or both eyes
- •Previous significant ocular trauma, laser or incisional surgery within 3 months of the screening visit
- •Traumatic cataract surgery with an open posterior capsule or any patient with an anterior chamber intraocular lens implant or aphakia
- •IOP in either eye exceeding 34 mmHg (mean diurnal IOP on Day 1 before treatment at 8 am, 12 pm and 4 pm).
- •Any corneal abnormalities preventing reliable applanation tonometry.
- •Patients at risk of angle closure or evidence of acute, intermittent or chronic angle closure
- •Forms of glaucoma resulting from conditions other than primary open-angle glaucoma or ocular hypertension, such as pigmentary or pseudo-exfoliative glaucoma.,
- •Pupil with inadequate ability to dilate sufficiently for peripheral retinal examination.
- •History or evidence of Herpes simplex keratitis.
- •Patients with known risk factors for macular oedema.
- •Patients suffering from reactive airway disease including bronchial asthma or with a history of bronchial asthma or severe chronic obstructive pulmonary disease.
- •Patients suffering from Sinus bradycardia, sick sinus syndrome, sino-atrial block, second- or third-degree atrioventricular block not controlled with a pacemaker, overt cardiac failure, or cardiogenic shock.
- •Patients, for which the absorption of the beta blocking agent, timolol, may in the Investigator’s opinion acerbate pre-existing systemic conditions, such as cardiac, vascular or respiratory disorders, hypoglycaemia or diabetes.
- •Hypersensitivity to the active substances or to any of the excipients of the test or reference products.
研究者
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