EUCTR2007-004212-31-CZ进行中（未招募）不适用
A Double-Masked, Multiple-Dose, Study of the IOP-Lowering Efficacy of Brinzolamide 1.0% Compared to Placebo When Added to Travoprost 0.004%/Timolol 0.5% Fixed Combination as Adjunctive Therapy in Primary Open-Angle Glaucoma or Ocular Hypertensive Patients - ADAPT
适应症
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
- 160
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 have a clinical diagnosis of ocular hypertension, primary open-angle, exfoliation, or pigment dispersion glaucoma in at least one eye (study eye).
- •- Must have been treated with a prostaglandin agent alone or in combination with adjunctive drugs in fixed or unfixed combinations for a minimum of two weeks at Visit 1 and have an intraocular pressure of between 21 and 32 mm Hg inclusive in at least one eye and = 32 mm Hg in both eyes at Visit 1.
- •- Must have an IOP between 19 and 32 mm Hg inclusive at the 8:00 AM measurement in at least one eye and = 32 mm Hg at all time points in both eyes at Visit 2.
- •- Must have best corrected visual acuity of 6/30 (20/100 Snellen, 0.7 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
- •- Intraocular conventional surgery or laser surgery in study eye(s) less than three months prior to Visit 1.
- •- Women of childbearing potential
- •- Any clinically significant, serious, or severe medical or psychiatric condition.
- •- Participation in any other investigational study within 30 days prior to Visit 1.
- •- Known medical history of allergy or sensitivity to any components of the preparations to be used in this trial that is deemed clinically significant in the opinion of the Principal Investigator (sulfa or BAC allergy).
- •- Concomitant administration of an oral carbonic anhydrase inhibitor.
- •- 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 30 days prior to Visit 1 or an anticipated change in the dosage during the course of the study.
- •- History of bronchial asthma, or chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker.
- •- A history of, or at risk for uveitis or cystoid macular edema (CME).
- •- History of ocular herpes simplex.
- •- Fuch’s corneal dystrophy, moderate to severe guttata, or a subjectively low endothelial cell count by slit lamp biomicroscopy.
- •- Use of contact lenses, unless patients agree to remove them prior to instillation of study medication and wait a minimum of fifteen minutes following drug instillation before re-inserting the lenses.
研究者
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