CTRI/2010/091/000523已完成4 期
Assessing the Safety and Efficacy of Changing to Travacom® (Travoprost/Timolol Fixed Combination), as replacement therapy in patients with uncontrolled intraocular pressure across India - start2
Alcon laboratoriesIndia Pvt Ltd0 个研究点目标入组 600 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 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
入排标准
入选标准
- •Must be at least 18 years of age.Must have a clinical diagnosis of ocular hypertension, primary open-angle or pigment dispersion glaucoma in both eyes.
- •Must be on a stable regimen IOP lowering medication (either a single therapets) within 1 week of the Screening Visit.utic agent or two separate ocular hypotensive agen
- •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.
- •Must have an IOP of between 19 to 35 mmHg in at least one eye (which would be the study eye). In the eye that is not included in the study, the IOP should be able to be controlled on no pharmacologic therapy or on the study medicine alone.
- •Must be willing to discontinue the use of all other ocular hypotensive medications prior to receiving the study medication for the entire course of the study.
- •Must be able to follow instructions and be willing and able to attend all study visits.
- •Must have best corrected visual acuity of 6/60 (20/200 Snellen, 1.0 LogMAR) or better in each eye.
排除标准
- •A known medical history of allergy, hypersensitivity or poor tolerance to any component of Travacom that is deemed clinically significant in the opinion of the Principal Investigator.
- •Any abnormality preventing reliable applanation tonometry in either eye. Corneal dystrophies. Any opacity or subject uncooperativeness that restricts adequate examination of the ocular fundus or anterior chamber of either eye. Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye. Blepharitis or non-clinically significant conjunctival injection is allowed. Intraocular conventional surgery or laser surgery in either eye that is less than three months prior to the Screening Visit. Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator?s best judgment. rogressive retinal or optic nerve disease from any cause. A history of, or at risk for uveitis or cystoid macular edema (CME). 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. 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. Sinus bradycardia ( < 50 beats per minute), second- or third-degree atrioventricular block, sino-atrial block, overt cardiac failure, or cardiogenic shock that would preclude the safe administration of a topical beta-blocker.
- •13.Any clinically significant, serious, or severe medical or psychiatric condition. Women of childbearing potential. Women who are pregnant or lactating. 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. Participation in any other investigational study within 30 days prior to the Screening Visit.
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