EUCTR2010-022965-82-NL进行中（未招募）不适用
A phase III, randomized, double-masked 6-month clinical study to compare the efficacy and safety of the preservative-free fixed-dose combination of tafluprost 0.0015% and timolol 0.5% eye drops to those of tafluprost 0.0015% and timolol 0.5% eye drops given as individual monotherapies in patients with open angle glaucoma or ocular hypertension
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Santen Oy
- 入组人数
- 600
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
- •1. Aged 18 years or more
- •2. A diagnosis of ocular hypertension or open-angle glaucoma (either
- •POAG, capsular glaucoma or pigmentary glaucoma) in one or both eyes,
- •for which the patient has been regularly using prostaglandin (e.g.
- •XML File Identifier: zxq2/87noAHilW6kubzcCMT2L+8=
- •Xalatan®, Lumigan®, Travatan®, Taflotan®) or timolol 0.5% (several
- •brand names) monotherapy for at least two weeks before Screening
- •(confirmed in anamnesis).
- •3. Clinical need for additional IOP lowering medication as judged by the
- •investigator and at the Screening visit evaluation in either treated eye:
- •o IOP measurement of = 22 mmHg at any time of the day for prior
- •timolol users (stratum 1)
- •o IOP measurement of = 20 mmHg at any time of the day for prior
- •prostaglandin users (stratum 2)
- •4. At the End-of-run-in visit after 2-week treatment with preservativefree
- •timolol 0.5% (stratum 1) or with preservative-free tafluprost
- •0.0015% (stratum 2) in either treated eye:
- •o IOP measurement of = 22 mmHg at 8:00 for prior timolol users
- •(stratum 1)
- •o IOP measurement of = 20 mmHg at 8:00 for prior prostaglandin users
- •(stratum 2)
- •5. At the Baseline visit after a washout period of at least 4 weeks in
- •either eye:
- •o An increase of at least 2 mmHg in the average diurnal IOP (measured
- •at 8:00, 10:00, 16:00 and 20:00) as compared to the average diurnal IOP
- •at the End-of-run-in visit
- •6. A best corrected ETDRS visual acuity score of +0.6 logMAR or better
- •in both eyes (i.e. monocular patients are not eligible)
- •7. Are willing to follow instructions
- •8. Have provided a written informed consent
- •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 180
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 420
排除标准
- •1. Females who are pregnant, nursing or planning pregnancy, or
- •females of childbearing potential who are not using a reliable method of
- •contraception
- •2. Anterior chamber angle in either eye to be treated less than grade 2
- •according to Schaffer classification as measured by gonioscopy
- •3. Any corneal abnormality or other condition preventing reliable
- •applanation tonometry in the treated eyes, including prior refractive eye
- •4. IOP of 35 mmHg or greater at any time point in either eye at
- •Screening or End-of-run-in visits
- •5. Diagnosis of angle-closure glaucoma or secondary glaucoma other
- •than capsular or pigmentary glaucoma in either eye
- •6. Suspected contraindication to tafluprost or timolol therapy;
- •a. hypersensitivity to tafluprost/timolol or any of the excipients
- •b. low heart rate of <50 bpm (at Screening visit) or clinically relevant
- •low blood pressure for age, chronic obstructive pulmonary disease,
- •bronchial asthma, strong tendency to bronchospasm, certain cardiac
- •arrhythmias, the most common of which are second or third degree AV
- •block and bradycardia, or uncontrolled congestive heart failure
- •c. also for washout medication Azopt® (use of which is judged by the
- •investigator): hypersensitivity to brinzolamide or any of the excipients,
- •known hypersensitivity to sulphonamide, severe renal insufficiency or
- •XML File Identifier: zxq2/87noAHilW6kubzcCMT2L+8=
- •hyperchloraemic acidosis
- •7. Glaucoma filtration surgery or any other ocular surgery (including
- •ocular laser procedures) within 6 months prior to Screening in eye(s) to
- •be treated with study medication
- •8. Use of contact lenses at Screening or during the study
- •9. Advanced visual field defect in either eye or anticipated progression
- •during the study as judged by the investigator
- •10. Inability to safely discontinue the use of ocular hypotensive
- •medications during the washout period
- •11. Any ocular (e.g. aphakia, pseudophakia with torn posterior lens
- •capsule or anterior chamber lenses, known risk factors for cystoid
- •macular oedema or iritis/uveitis), systemic or psychiatric
- •disease/condition (e.g. uncontrolled arterial hypertension, diabetes)
- •that may put the patient at a significant risk or may confound the study
- •results or may interfere significantly with the patient's participation in
- •the study as judged by the investigator
- •12. Change of an existing chronic therapy that could substantially affect
- •the IOP or the study outcomes within 30 days prior to Visit 1, or
- •anticipated change in such therapy during the study
- •13. Current alcohol or drug abuse
- •14. Current participation in another clinical trial involving an
- •investigational drug/device, or participation in such a trial within the
- •last 30 days
研究者
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