EUCTR2010-021973-35-CZ进行中（未招募）不适用
Assessing the Safety and Efficacy of Changing to DuoTrav® (Travoprost 0.004%/Timolol 0.5% Fixed Combination), as Replacement Therapy in Patients Uncontrolled on Bimatoprost 0.03%/Timolol 0.5% Therapy (Fixed or Unfixed)
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
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.Must be at least 18 years of age.
- •2.Must have a clinical diagnosis of ocular hypertension, primary open-angle or pigment dispersion glaucoma in both eyes.
- •3.Must be on a stable IOP lowering regimen within 4 weeks prior to the Screening Visit.
- •4.Must have IOP considered to be safe (in the opinion of the investigator), in both eyes, in such a way that should assure clinical stability of vision and the optic nerve throughout the study period.
- •5.Must have an IOP of between 19 to 35 mmHg (at any time of the day) in at least one eye (which would be designated as the study eye). In any eye not designated as a study eye, the IOP should be able to be controlled on no pharmacologic therapy or on the study medicine alone.
- •6.Must be willing to discontinue the use of all other ocular hypotensive medication(s) prior to receiving the study medication for the entire course of the study.
- •7.Must be able to follow instructions and be willing and able to attend all study visits.
- •8.Must have best corrected visual acuity of 6/60 (20/200 Snellen, 1.0 LogMAR) or better in each eye.
- •9.An Ethics Committee reviewed and approved (for use in this study) informed consent form must be read, signed, and dated by the participating subject, as well as signed and dated by the individual (Principal Investigator or other site personnel) obtaining the informed consent, before conducting the Screening Visit and prior to initiation of study procedures.
- •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.Known medical history of allergy, hypersensitivity or poor tolerance to any component of DuoTrav® that is deemed clinically significant in the opinion of the Principal Investigator.
- •2.Any abnormality preventing reliable applanation tonometry in either eye.
- •3.Corneal dystrophies in either eye.
- •4.Any opacity or subject uncooperativeness that restricts adequate examination of the ocular fundus or anterior chamber of either eye.
- •5.Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye. Blepharitis or non-clinically significant conjunctival injection is allowed.
- •6.History of ocular herpes simplex.
- •7.Intraocular conventional surgery or laser surgery in either eye that is less than three months prior to the Screening Visit.
- •8.Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator’s best judgment.
- •9.Progressive retinal or optic nerve disease from any cause apart from glaucoma.
- •10.Use of systemic medications known to affect IOP (e.g., oral beta-adrenergic blockers, alpha-agonists and blockers, angiotensin converting enzyme inhibitors and calcium channel blockers), which have not been on a stable course for 7 days prior to Screening Visit or an anticipated change in the dosage during the course of the study.
- •11.Bronchial asthma or a history of bronchial asthma, bronchial hyper reactivity, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker.
- •12.Sinus bradycardia (< 50 beats per minute), second- or third-degree atrioventricular block, sino-atrial block, overt cardiac failure, myasthenia gravis or cardiogenic shock that would preclude the safe administration of a topical beta-blocker.
- •13.History of severe allergic rhinitis.
- •14.Unwillingness to risk the possibility of darkened iris or eyelash changes.
- •15.A history of, or at risk for uveitis or cystoid macular edema (CME).
- •16.Any clinically significant, serious, or severe medical or psychiatric condition.
- •17.Women of childbearing potential not using a reliable method of birth control.
- •18.Women who are pregnant or lactating.
- •19.A condition, which in the opinion of the Principal Investigator, would interfere with optimal participation in the study, or which would present a special risk to the subject.
- •20.Participation in any other investigational study within 30 days prior to the Screening Visit.
研究者
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