EUCTR2009-010101-36-DE进行中（未招募）1 期
The Efficacy and Safety of Adding the Brinzolamide/Timolol Maleate Fixed Combination (Azarga®) to Prostaglandin Monotherapy
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
入选标准
- •Patients must be at least 21 years of age.
- •Must be able to follow instructions and be willing and able to attend required study visits.
- •Must have a clinical diagnosis of ocular hypertension, primary open-angle, or pigment dispersion glaucoma in at least one eye (qualifying eye).
- •Must have IOP considered to be safe, in both eyes, in such a way that should assure clinical stability of vision and the optic nerve throughout the trial.
- •In eyes not treated in the study the intraocular pressure should be able to be considered uncontrolled on prostaglandin monotherapy.
- •Must have been treated with monotherapy for a minimum of four weeks at Visit 1. Also, the last dose of their prostaglandin must have been instilled correctly so the patient is within the dosing cycle at Visit 1.
- •At Visit 1, have an intraocular pressure of = 20 mm Hg in at least one eye and = 35 mm Hg in both eyes treated with prostaglandin monotherapy.
- •Must have best corrected visual acuity of 6/60 (6/60 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 5.1.4.
- •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).
- •Any abnormality preventing reliable applanation tonometry in qualifying eye(s).
- •Presence of corneal dystrophies.
- •Any opacity or patient 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 qualifying eye(s) less than three months prior to Visit 1.
- •Risk of visual field or visual acuity worsening as a consequence of participation in the trial, in the investigator’s best judgment.
- •Progressive retinal or optic nerve disease from any cause apart from glaucoma.
- •Women of childbearing potential not using reliable means of birth control.
- •Women who are pregnant or lactating.
- •Any clinically significant, serious, or severe medical or psychiatric condition.
- •A condition, which in the opinion of the investigator, would interfere with optimal participation in the study, or which would present a special risk to the patient.
- •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 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.
- •Use of systemic carbonic anhydrase inhibitors (e.g., methazolamide [Neptazane], acetazolamide [Diamox])
- •Current or anticipated use of systemic corticosteroids, by any route except inhaled, for greater than two weeks during the trial.
- •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 (< 55 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.
- •History of myasthenia gravis.
- •History of an allergy to sulfa.
- •Unwillingness to accept the risk of iris, skin, or eyelash changes associated with prostaglandin therapy.
- •A history of, or at risk for uveitis or cystoid macular edema (CME).
- •History of ocular herpes simplex.
研究者
相似试验
进行中（未招募）
不适用
Comparison of Safety and Efficacy of Brinzolamide/Timolol Fixed Combination vs COSOPT in Patients with Open-Angle Glaucoma or Ocular Hypertension - Brinzolamide/Timolol Fixed Combination vs COSOPTEUCTR2005-004766-16-BEAlcon Research, Ltd.420
进行中（未招募）
不适用
Comparison of Safety and Efficacy of Brinzolamide/Timolol Fixed Combination vs COSOPT in Patients with Open-Angle Glaucoma or Ocular Hypertension - Brinzolamide/Timolol Fixed Combination vs COSOPTOpen Angle Glaucoma or Ocular HypertensionICD: H40.1/H40.0EUCTR2005-004766-16-SEAlcon Research, Ltd.420
进行中（未招募）
不适用
Comparison of Safety and Efficacy of Brinzolamide/Timolol Fixed Combination vs COSOPT in Patients with Open-Angle Glaucoma or Ocular Hypertension. - Brinzolamide/Timolol Fixed Combination vs COSOPTOpen-Angle Glaucoma or Ocular HypertensionEUCTR2005-004766-16-LTAlcon Research, Ltd.420
进行中（未招募）
不适用
Comparison of Safety and Efficacy of Brinzolamide/Timolol Fixed Combination vs COSOPT® in Patients with Open-Angle Glaucoma or Ocular Hypertension. - Brinzolamide/Timolol Fixed Combination vs COSOPTOpen –Angle Glaucoma or Ocular HypertensionEUCTR2005-004766-16-LVAlcon Research, Ltd.420
进行中（未招募）
1 期
Comparison of Safety and Efficacy of Brinzolamide/Timolol Fixed Combination vs COSOPT in Patients with Open-Angle Glaucoma or Ocular Hypertension - Brinzolamide/Timolol Fixed Combination vs COSOPTEUCTR2005-004766-16-GBAlcon Research, Ltd.