EUCTR2016-000946-69-AT进行中（未招募）1 期
A PHASE III, MULTICENTRE, RANDOMISED, INVESTIGATOR-MASKED, CROSS- OVER, COMPARATIVE CLINICAL TRIAL EVALUATING THE EFFICACY AND SAFETY OF THE GENERIC BRINZOLAMIDE 10 MG/ML + TIMOLOL 5 MG/ML EYE DROPS SUSPENSION (AZAD PHARMA AG) WITH BRINZOLAMIDE 10 MG/ML + TIMOLOL 5 MG/ML EYE DROPS SUSPENSION AZARGA® (ALCON LTD) IN OPEN- ANGLE GLAUCOMA AND OCULAR HYPERTENSION PATIENTS - Azad Brinolamid/Timolol combination generic study
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 66
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. Elevated IOP / primary open angle glaucoma (irideocorneal angle > 30°) in at least one
- •eye: IOP pre-treatment (measured at approx. 8 am, 10 am and 4 pm) must be equal or
- •higher than 22 mmHg, and equal or lower to 35 mmHg (untreated, i.e. naïve or after
- •2. Not on any ophthalmic pressure-lowering medication, or in the condition not to suffer
- •an untoward effects by withdrawal from current pressure-lowering medications for the
- •washout period(s).
- •3. No ocular trauma, surgery, inflammation or infection, no corneal foreign body in the
- •previous 3 months.
- •4. No clinically significant or progressive retinal disease as determined by dilated
- •peripheral retinal examination done at screening.
- •5. No concomitant use of any topical ophthalmic medication other than artificial tears.
- •6. No ocular glucocorticoids in the previous 3 months.
- •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 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •1. Visual acuity of less than distance Snellen 20/100 corresponding to decimal 0.20 or 0.70
- •logMAR in either eye.
- •2. Evidence of acute ocular infection, corneal foreign body, or ocular inflammation.
- •3. Previous significant ocular trauma, laser or incisional surgery within 3 months of the
- •screening visit.
- •4. Any corneal abnormalities preventing reliable applanation tonometry.
- •5. Patients with risk of angle closure or evidence of acute, intermittent or chronic angle
- •6. Types of glaucoma other than POAG with glaucomatous optic disc morphology or
- •glaucoma visual field defect such as pigmentary or pseudo-exfoliative glaucoma.
- •7. Pupil with inadequate ability to dilate sufficiently for peripheral retinal examination.
- •8. History or evidence of severe inflammatory eye disease (i.e. uveitis, retinitis, scleritis) in
- •one or both eyes.
- •9. Traumatic cataract surgery with an open posterior capsule or any patient with an anterior
- •chamber intraocular lens implant or aphakia
- •10. Pregnant or nursing women.
- •11. History of drug or alcohol abuse within the last 6 months.
- •12. A history of hypersensitivity to Brinzolamide, Timolol, sulphonamides or any component
- •in the formulation of the products being tested.
- •13. Patient with history of severe renal insufficiency (Creatinin Clearance <30ml/min) or
- •hyperchloremic acidosis.
- •14. Patients with reactive airway disease including bronchial asthma or a history of bronchial
- •asthma, or severe chronic obstructive pulmonary disease.
- •15. Patients with sinus bradycardia, sick sinus syndrome, sino-atrial block, second or third
- •degree atrioventricular block not controlled with pace-maker. Overt cardiac failure,
- •cardiogenic shock.
- •16. Patients with severe allergic rhinitis.
- •17. Patients who have participated in another research study for an investigational drug within
- •30 days of the screening visit.
- •18. History of evidence of any medical condition that would, in the opinion of the investigator,
- •make the patient unsuitable for the study.
- •19. Systemic medication that may alter IOP in the previous 30 days (i.e. beta-blockers, Calcium
- •channel blockers, angiotensin converting enzyme (ACE) inhibitors, prostaglandins etc.) or not expected to continue the current treatment with these medical products on a stable
- •regimen for 30 days prior to the study and during the study.
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