NL-OMON36182已完成3 期
Efficacy and Safety of Brinzolamide 10 mg/ml / Brimonidine 2 mg/ml Eye Drops, Suspension Compared to Brinzolamide 10 mg/ml Eye Drops, Suspension plus Brimonidine 2 mg/ml Eye Drops, Solution in Patients with Open-Angle Glaucoma or Ocular Hypertension. - Brinz/Brim BID versus Brinzolamide + Brimonidine BID in OAG or OHT
Alcon Laboratories0 个研究点目标入组 36 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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 currently on multiple IOP-lowering medications.
- •2) Mean IOP measurements in at least one 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 Eligibility 1 and Eligibility 2 Visits, following wash-out of any IOP-lowering medication.
- •Mean IOP must not be > 36 mmHg at any time point.
- •3) Must be able to understand and sign an informed consent form that has been approved by an Independent Ethics Committee
排除标准
- •1. Women of childbearing potential (who are not postmenopausal for at least 1 year or surgically sterile) are excluded from participation if they are currently pregnant, have a positive result on the urine pregnancy test at Screening, or intend to become pregnant during the study period; are breast-feeding; are not in agreement to use adequate birth control methods (see the Manual of Procedures) to prevent pregnancy throughout the study.
- •2. Schaffer angle Grade < 2 as measured by gonioscopy (extreme narrow angle with complete or partial closure).
- •3. Cup/disc ratio (C/D) greater than 0.80 (horizontal or vertical measurement).
- •4. 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 undergo the initial wash-out period discontinuing all IOP-lowering ocular medication(s) for a minimum of 5 (± 1) to 28 (± 1) days prior to 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 0.60 logMAR, 20/80 Snellen, or 0.25 decimal).
- •11. Other ocular pathology (including severe dry eye) that may, in the opinion of the Investigator, preclude the administration of a-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 a-adrenergic agonist or CAI in the opinion of the investigator.
- •17. Recent (within 4 weeks of the E1 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 inhibitors (MAOI).
- •20. Concurrent use of glucocorticoids administered by any route.
- •21. Therapy with another investigational agent within 30 days prior to the Screening Visit.
- •22. Hypersensitivity to a-adrenergic agonist drugs, topical or oral CAIs, sulfonamide derivatives, or to any component of the study medications in the opinion of the Investigator.
- •23. 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 β-adrenergic blocking agents.
- •24. Use of any additional topical or systemic ocular hypotensive medication during the study.
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Effect and safety of eyedrops containing two medicines (Brinzolamide 10 mg/ml/Brimonidine 2 mg/ml Eye Drops, Suspension) compared with the simultaneous use of the two medicines separately (Brinzolamide 10 mg/ml Eye Drops, Suspension plus Brimonidine 2 mg/ml Eye Drops, Solution) in patients with increased eye pressure (ocular hypertension) or with associated changes to nerve inside the eye (glaucoma).Patients with open-angle glaucoma or ocular hypertensionMedDRA version: 13.1Level: HLGTClassification code 10018307Term: Glaucoma and ocular hypertensionSystem Organ Class: 10015919 - Eye disordersEUCTR2010-024513-31-ATAlcon Research, Ltd.820
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Effect and safety of eyedrops containing two medicines (Brinzolamide 10 mg/ml/Brimonidine 2 mg/ml Eye Drops, Suspension) compared with the simultaneous use of the two medicines separately (Brinzolamide 10 mg/ml Eye Drops, Suspension plus Brimonidine 2 mg/ml Eye Drops, Solution) in patients with increased eye pressure (ocular hypertension) or with associated changes to nerve inside the eye (glaucoma).Patients with open-angle glaucoma or ocular hypertensionMedDRA version: 14.1Level: HLGTClassification code 10018307Term: Glaucoma and ocular hypertensionSystem Organ Class: 10015919 - Eye disordersEUCTR2010-024513-31-PTAlcon Research, Ltd.820