EUCTR2014-005273-37-DE进行中（未招募）1 期
A phase IV study on the changes in ocular signs and symptoms in patientswith ocular hypertension or open-angle glaucoma switched from Ganfort® eye drops (bimatoprost 0.03%/timolol 0.5%) to Taptiqom® eye drops (tafluprost 0.0015%/timolol 0.5%)
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
- Santen Oy
- 入组人数
- 120
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 or PEX) in one or both eyes, for which the patient has been regularly using Ganfort® in the evening for at least 4 weeks before Screening.
- •3. In the Screening visit evaluation, the presence of:
- •- conjunctival redness/hyperemia at least in one treated eye
- •- at least one ocular symptom considered for the two eyes together
- •(irritation/burning/stinging, foreign body sensation, tearing, itching or dry eye
- •4. A best corrected ETDRS visual acuity score of +0.6 logMAR or better in both eyes
- •5. Have provided a written informed consent and are willing to follow instructions
- •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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 70
排除标准
- •1. Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception
- •2. Use of more than two active medicinal agents to treat glaucoma/OH during the past six months prior to Screening
- •3. Anterior chamber angle in either eye to be treated less than grade 2 according to Schaffer classification as measured by gonioscopy
- •4. Any corneal abnormality or other condition preventing reliable applanation tonometry,including prior refractive eye surgery
- •5. IOP greater than 21 mmHg in treated eye(s) at Screening/Baseline visit
- •6. Use of preserved eye drops (other than Ganfort®) including artificial tears at screening or within two weeks prior to screening visit
- •7. Diagnosis of angle-closure glaucoma or secondary glaucoma other than PEX in either eye
- •8. Suspected contraindication to tafluprost or timolol therapy (low heart rate or clinically relevant low blood pressure for age, chronic obstructive pulmonary disease, bronchial asthma, strong tendency to bronchospasm, certain cardiac arrhythmias or uncontrolled congestive heart failure)
- •9. 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
- •10. Use of contact lenses at Screening or during the study
- •11. Any ocular, systemic or psychiatric disease/conditio that may put the patient at a significant risk or may confound the study results as judged by the investigator
- •12. Current alcohol or drug abuse
- •13. Current participation in another clinical trial involving an investigational drug/device, or participation in such a trial within the last 30 days prior to Screening
研究者
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