EUCTR2008-002781-66-ES进行中（未招募）1 期
Estudio multicéntrico, doble enmascarado, de doce meses con la combinación fija de Travoprost/Brinzolamida QD AM y la combinación fija de Travoprost/Brinzolamida QD PM versus COSOPT BID en pacientes con glaucoma de ángulo abierto o hipertensión ocular.A twelve-month, multicenter, double-masked study of Travoprost / Brinzolamide fixed combination QD AM and Travoprost / Brinzolamide fixed combination QD PM versus COSOPT BID in patients with open-angle glaucoma or ocular hypertension - Travoprost / Brinzolamide Fixed Combination Once-Daily vs. COSOPT
适应症
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
- •Patients of either sex and any race, 18 years of age or older, diagnosed with open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component) or ocular hypertension.
- •Patients inadequately controlled on a current stable (i.e., at least 4 weeks) IOP lowering medication. Inadequately controlled is defined as having a mean IOP = 18 mmHg in at least one eye at the Screening Visit.
- •Patients must meet the following IOP entry criteria in at least one eye: For each qualifying eye, the mean IOP must be: = 24 mmHg and = 36 mmHg at the 9:00 time point at both Eligibility Visits 1 and 2, and = 21 mmHg and = 36 mmHg at the 11:00 and 16:00 time points at both Eligibility Visits 1 and 2.The same eye(s) must qualify at all qualifying time points at both Eligibility Visits 1 and 2. The mean IOP is the average of IOP measurements in the same eye.
- •Patients must be able to discontinue use of all IOP-lowering medication(s) for a minimum period of 5 days to 28 days prior to Eligibility Visit 1.
- •Patients must be on a stable dosing regimen of medications affecting IOP for at least 30 days prior to the Screening Visit and must not change the dosing regimen during the eligibility period
- •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
- •Females of childbearing potential (those who are not surgically sterilized or at least two years post-menopausal) are excluded from participation in the study
- •Patients with any form of glaucoma other than open-angle glaucoma (with or without pigment dispersion or pseudo-exfoliation component) or confirmed ocular hypertension.
- •Patients with iridocorneal angle Shaffer grade < 2 (extreme narrow angle with complete or partial closure) in either eye, as measured by gonioscopy.
- •Patients with a cup/disc ratio greater than 0.80 (horizontal or vertical measurement) in either eye.
- •Patients with severe central visual field loss in either eye. Severe central field loss is defined as a sensitivity of = 10 dB in at least 2 of the 4 visual field test points closest to the point of fixation.
- •History of, or current chronic, recurrent, or severe inflammatory eye disease (e.g., scleritis, uveitis, herpes keratitis), or current other severe ocular pathology (including severe dry eye) that would affect the conduct of the study.
- •History of ocular trauma within the past 6 months.
- •Intraocular surgery within the past 6 months.
- •Ocular laser surgery within the past 3 months.
- •Best-corrected visual acuity score worse than 55 ETDRS letters read (equivalent to approximately 20/80 Snellen or 0.25 decimal or 0.6 logMAR)
- •Current ocular infection or inflammation, or history of ocular infection or inflammation within the past 3 months, as determined by patients’ history and/or examination.
- •History of, or current clinically relevant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment.
- •Any corneal abnormality preventing reliable applanation tonometry.
- •History of, or current 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) that would preclude the safe administration of a topical beta-blocker.
- •History of, or current bronchial asthma, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker.
- •History of, or current evidence of severe illness or any other conditions which would make the patient, in the opinion of the Investigator, unsuitable for the study.
- •History of severe or serious hypersensitivity to prostaglandin analogues, to CAIs, to beta-blockers or to any components of the study medications
- •Patients likely to use additional topical or systemic ocular hypotensive medication during the study.
- •Patients who cannot safely discontinue all glucocorticoid medications administered by any route.
- •Recent (within 4 weeks of Eligibility 1 Visit) use of high dose (> 1 gram daily) salicylate therapy.
- •History of uncontrolled diabetes or hypoglycemic episodes.
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