EUCTR2010-024512-34-IT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), must be: • = 24 mmHg and = 36 mmHg at the 9 AM time point and, • = 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: 0
- •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 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, such as: Hormonal – oral, implanted, Transdermal, or injected contraceptives; Mechanical – spermicide in conjunction with a barrier such as a condom or diaphragm or IUD. 2. Patients with Schaffer angle Grade < 2, as measured by gonioscopy (extreme narrow angle with complete or partial closure). 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. 6. 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 months. 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 insufficiency), hepatic, or renal disease that would preclude the safe administration of a topical alpha-adrenergic agonist or CAI in the opinion of the investigator. 17. Patients with recent (within 4 weeks of the Eligibility 1 Visit) use of high-dose (> 1 g daily) salicylate therapy. 18. Current or anticipated treatment with any psychotropic drugs that augment adrenergic response (eg, desipramine, amitriptyline). 19. Concurrent use of monoamine oxidase inhibitor. 20. Therapy with another investigational agent within 30 days prior to the Screening Visit. 21. Hypersensitivity to alpha-adrenergic agonist drugs, topical or oral CAIs, sulfonamide derivatives, or to any component of the study medications in the opinion of the Investigator. 22. Less than 30 days stable dosing regimen before the Screening Visit of any medications or substances administered by any route and used on a chronic basis that may affect IOP, including but not limited to, ß-adrenergic blocking agents. 23. Use of any additional topical or systemic ocular hypotensive medication dur
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