EUCTR2010-024512-34-HU进行中（未招募）不适用
Safety and IOP-Lowering Efficacy of Brinzolamide 10 mg/ml / Brimonidine 2 mg/ml Fixed Combination Eye Drops, Suspension compared to Brinzolamide 10 mg/ml Eye Drops, Suspension and Brimonidine 2 mg/ml Eye Drops, Solution in Patients with Open-Angle Glaucoma or Ocular Hypertension - Brinz/Brim BID FC vs Brinzolamide BID and Brimonidine BID in Patients with OAG
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
- 525
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
- •1. Patients 18 years of age or older, of either gender, and any
- •race/ethnicity, diagnosed with open angle glaucoma or ocular
- •hypertension, who in the opinion of the Investigator are
- •insufficiently controlled on monotherapy or are already on
- •multiple IOP-lowering medications.
- •2. Patients should be able to understand and sign an informed
- •consent that has been approved by an Institutional Review
- •Board/Independent Ethics Committee.
- •3. Mean IOP measurements in at least 1 eye, the same eye(s),
- •= 24 mmHg and = 36 mmHg at the 9 AM time point
- •= 21 mmHg and = 36 mmHg at the 11 AM time point at
- •both E1 and E2 Visits.
- •IOP must not be > 36 mmHg at any time point.
- •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 275
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 250
排除标准
- •1. Females of childbearing potential (those who are not surgically
- •sterilized or post-menopausal for at least 1 year) are excluded
- •from participation in the studyif they meet any one of the
- •following conditions:
- •a. are currently pregnant or,
- •b. have a positive result on the urine pregnancy test at the
- •Screening Visit or,
- •c. intend to become pregnant during the study period or,
- •d. are breast-feeding or,
- •e. they are not using highly effective birth control measures,
- •oral, implanted, transdermal, or injected
- •contraceptives;
- •Mechanical –
- •spermicide in conjunction with a barrier such
- •as a condom or diaphragm or IUD.
- •Patients with Schaffer angle Grade < 2, as measured by
- •gonioscopy (extreme narrow angle with complete or partial
- •3. Patients with a cup/disc ratio (C/D) greater than 0.80
- •(horizontal or vertical measurement).
- •4. Patients with severe central visual field loss. Severe central
- •visual field loss is defined as a sensitivity of less than or equal
- •to 10 dB in at least 2 of the 4 visual field test points closest to
- •the point of fixation.
- •5. Patients who cannot safely discontinue use of all IOPlowering
- •ocular medication(s) for a minimum period of 5 days
- •± 1 day to 28 days ± 1 day prior to Eligibility 1 (E1) Visit.
- •Chronic, recurrent or severe inflammatory eye disease
- •(ie, scleritis, uveitis, herpes keratitis).
- •7. Ocular trauma within the past 6 months.
- •8. Ocular infection or ocular inflammation within the past 3
- •9. Clinically significant or progressive retinal disease such as
- •retinal degeneration, diabetic retinopathy, or retinal
- •detachment.
- •10. Best-corrected visual acuity (BCVA) score worse than 55
- •ETDRS letters (equivalent to approximately 20/80 Snellen,
- •0.60 logMAR, or 0.25 decimal).
- •11. Other ocular pathology (including severe dry eye) that may, in
- •the opinion of the Investigator, preclude the administration of
- •alpha-adrenergic agonist and/or topical carbonic anhydrase
- •inhibitor (CAI).
- •12. Intraocular surgery within the past 6 months.
- •13. Ocular laser surgery within the past 3 months.
- •14. Any abnormality preventing reliable applanation tonometry.
- •15. Any other conditions including severe illness which would
- •make the patient, in the opinion of the Investigator, unsuitable
- •for the study.
- •16. History of active, severe, unstable or uncontrolled
- •cardiovascular (eg, coronary insufficiency, hypertension,
- •Raynaud’s phenomenon, orthostatic hypotension,
- •thromboangiitis obliterans), cerebrovascular (eg, cerebral
- 另有 18 项未显示
研究者
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