EUCTR2006-005237-38-DE进行中（未招募）不适用
SAFETY AND EFFICACY OF SWITCHING TO THE TRAVOPROST/TIMOLOL MALEATE FIXED COMBINATION (DUOTRAV) FROM PRIOR MONO- OR TWO-DRUG THERAPY IN GERMANY
适应症
相关药物
试验速览
- 阶段
- 不适用
- 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
- •Must be at least 18 years of age.
- •Must have a clinical diagnosis of ocular hypertension, primary open-angle or pigment dispersion glaucoma in at least one eye (study eye).
- •Must have been treated with mono- or adjunctive therapy (in a fixed or unfixed combination) for a minimum of one week at Visit 1. Also, the last dose of the previous medicine must have been instilled correctly so the patient is within the dosing cycle at Visit 1.
- •Have an intraocular pressure of between 19 and 35 mm Hg inclusive in at least one eye and = 35 mm Hg in both eyes on monotherapy or between 19 and 32 mm Hg inclusive in at least one eye and = 32 mm Hg in both eyes on two-drug therapy at Visit 1.
- •Must have best corrected visual acuity of 6/60 (20/200 Snellen, 1.0 LogMAR) or better in each eye.
- •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
- •Presence of other primary or secondary glaucomas not listed in inclusion criterion.
- •Presence of extreme narrow angle with complete or partial closure in either eye, as measured by gonioscopy (occludable angles treated with a patent iridectomy are acceptable).
- •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 study eye(s) less than three months prior to Visit 1.
- •Women of childbearing potential not using reliable means of birth control
- •Women who are pregnant or lactating
- •Known medical history of allergy, sensitivity or poor tolerance to any components of the preparations to be used in this trial that is deemed clinically significant in the opinion of the Principal Investigator.
- •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 Visit 1 or an anticipated change in the dosage during the course of the study.
- •History of bronchial asthma, chronic obstructive pulmonary disease, decompensated heart failure, or second- or third-degree heart block that would preclude the safe administration of a topical beta-blocker.
- •Unwillingness to risk the possibility of darkened irides or eyelash changes
- •A history of, or at risk for uveitis or cystoid macular edema (CME).
- •History of ocular herpes simplex.
- •Sinus bradycardia (< 50 beats per minute).
- •Corneal dystropies.
- •Severe allergic rhinitis.
研究者
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