EUCTR2014-005273-37-IT进行中（未招募）1 期
A phase IV study on changes in ocular signs and symptoms in patients with with 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%) - Clinical Trial on changes in ocular signs and symptoms in patients with ocular hypertension or open
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
- 123
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
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 57
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 medication
- •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
相似试验
进行中（未招募）
1 期
A clinical trial on the changes in ocular signs and symptoms in patientswith ocular hypertension or open-angle glaucoma switched from Ganfort® eye drops to Taptiqom® eye drops.Glaucoma or Ocular HypertensionMedDRA version: 18.0Level: HLGTClassification code 10018307Term: Glaucoma and ocular hypertensionSystem Organ Class: 10015919 - Eye disordersMedDRA version: 18.0Level: PTClassification code 10030348Term: Open angle glaucomaSystem Organ Class: 10015919 - Eye disordersMedDRA version: 18.0Level: PTClassification code 10074026Term: Exfoliation glaucomaSystem Organ Class: 10015919 - Eye disordersEUCTR2014-005273-37-DESanten Oy120
进行中（未招募）
1 期
A clinical trial on the changes in ocular signs and symptoms in patientswith ocular hypertension or open-angle glaucoma switched from Ganfort® eye drops to Taptiqom® eye drops.Glaucoma or Ocular HypertensionMedDRA version: 17.1Level: HLGTClassification code 10018307Term: Glaucoma and ocular hypertensionSystem Organ Class: 10015919 - Eye disordersMedDRA version: 17.1Level: PTClassification code 10030348Term: Open angle glaucomaSystem Organ Class: 10015919 - Eye disordersMedDRA version: 17.1Level: PTClassification code 10074026Term: Exfoliation glaucomaSystem Organ Class: 10015919 - Eye disordersEUCTR2014-005273-37-FISanten Oy120
进行中（未招募）
不适用
A phase IIIb study on the changes in ocular signs, symptoms and conjunctival inflammatory markers in patients with ocular hypertension or open-angle glaucoma switched from preserved latanoprost 0.005% eye drops to preservative free tafluprost 0.0015% eye drops.EUCTR2007-004872-37-DESanten Oy150
进行中（未招募）
不适用
A phase IIIb study on the changes in ocular signs, symptoms and conjunctival inflammatory markers in patients with ocular hypertension or open-angle glaucoma switched from preserved latanoprost 0.005% eye drops to preservative free tafluprost 0.0015% eye drops.EUCTR2007-004872-37-SESanten Oy150
进行中（未招募）
不适用
A phase IIIb study on the changes in ocular signs, symptoms and conjunctival inflammatory markers in patients with ocular hypertension or primary open-angle glaucoma switched from preserved latanoprost 0.005% eye drops to preservative free tafluprost 0.0015% eye drops.Ocular hypertension or open angle glaucoma patients are enrolled into this trial.EUCTR2007-004872-37-FISanten Oy150