EUCTR2007-002501-45-GB进行中（未招募）1 期
Phase IV randomised double masked clinical trial: Assessing morning versus evening dosing of a fixed dose combination of Travoprost 0.004% / Timolol Maleate 0.5% in patients with primary open angle glaucoma or ocular hypertension. - DuoTrav: Morning versus evening
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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.Male or female adult patients over the age of 18 years
- •2.Open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion
- •component), or ocular hypertension.
- •3.Current treatment with prostaglandin analogue monotherapy, IOP-lowering medication.
- •4.Meet the following IOP entry criteria in at least one treated eye (mean IOP);
- •a.= 19 mmHg
- •b.= 28 mmHg
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Females of childbearing potential
- •2. Any form of glaucoma other than open-angle glaucoma (with or without a pigment dispersion or pseudo-exfoliation component).
- •3. Current or previous therapy with another investigational agent, within 30 days prior to study entry.
- •4. History of chronic or recurrent severe inflammatory eye disease (e.g., scleritis, uveitis, herpes keratitis), in either eye.
- •5. History of ocular trauma within the past six months in either eye
- •6. History of ocular infection or ocular inflammation within the past three months in either eye.
- •7. History of clinically significant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment in either eye.
- •8. History of any other severe ocular pathology (including severe dry eyes), in either eye that would preclude the administration of a topical prostaglandin analogue.
- •9. History of severe or serious hypersensitivity to prostaglandin drugs or their analogues, to topical or systemic beta-blockers, or to any components of the study medication.
- •10. Intraocular surgery within the past six months
- •11. Ocular laser surgery within the past three months
- •12. Angle grade less than Grade 2 in either eye, as measured by gonioscopy (extreme narrow angle with complete or partial closure), assessed within the previous 12 months.
- •13. Cup/disc ratio greater than 0.80 in either eye, assessed within the previous six months.
- •14. Severe central visual field loss in either eye, defined as a sensitivity of = 10 bB in at least two of the four visual field test points, closest to the point of fixation, assessed within the previous six months.
- •15. Unable to safely discontinue all IOP lowering medication, for a minimum period of 28 days prior to Baseline Visit.
- •16. History of severe, unstable or uncontrolled cardiovascular, hepatic or renal disease (e.g. sinus bradycardia, overt cardiac failure, greater than first degree atrioventricular block, cardiogenic shock, clinically relevant angina or uncontrolled hypertension), which would preclude the safe administration of a topical beta-blocker.
- •17. History of bronchial asthma, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker.
- •18. History or other evidence of severe illness or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study.
研究者
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