EUCTR2016-000946-69-HU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 Brinzolamide/Timolol combination 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.
- •7. Only for contact lens wearers: contact lenses must be removed prior to each drug application and be kept out for a minimum of 15 minutes after drug application. In addition contact lenses must remain out for a minimum of 20 minutes when ocular comfort assessments are required.
- •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 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
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
研究者
相似试验
进行中（未招募）
1 期
COMPARATIVE TRIAL OF GENERIC LATANOPROST + TIMOLOL (50µG + 5MG)/ML EYE DROPS, SOLUTION (POLPHARMA S.A.) COMPARED TO XALACOM® (LATANOPROST 0.005 % OPHTHALMIC SOLUTION & TIMOLOL 0.5% FIXED COMBINATION, PFIZER) IN PATIENTS WITH OCULAR HYPERTENSION OR PRIMARY OPEN ANGLE GLAUCOMA.Ocular hypertension and open angle glaucomaMedDRA version: 20.0Level: PTClassification code 10030043Term: Ocular hypertensionSystem Organ Class: 10015919 - Eye disordersMedDRA version: 20.0Level: PTClassification code 10030348Term: Open angle glaucomaSystem Organ Class: 10015919 - Eye disordersEUCTR2021-003387-27-HUPharmaceutical Works Polpharma S.A. (Polpharma S. A.)40
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) and of Brinzolamide 10 mg/ml + Timolol 5 mg/ml eye drops suspension Azarga® (Alcon Ltd) in open-angle glaucoma and ocular hypertension patientsDecrease of intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension for whom monotherapy provides insufficient IOP reductionMedDRA version: 19.0Level: HLGTClassification code 10018307Term: Glaucoma and ocular hypertensionSystem Organ Class: 10015919 - Eye disordersMedDRA version: 19.0Level: PTClassification code 10030043Term: Ocular hypertensionSystem Organ Class: 10015919 - Eye disordersEUCTR2016-000946-69-ATAZAD Pharma AG66
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) and of Brinzolamide 10 mg/ml + Timolol 5 mg/ml eye drops suspension Azarga® (Alcon Ltd) in open-angle glaucoma and ocular hypertension patientsEUCTR2016-000946-69-PLAZAD Pharma AG66
进行中（未招募）
1 期
EFFICACY AND TOLERABILITY OF GENERIC LATANOPROST 0.05 MG/ML EYE DROPSSOLUTION (POLPHARMA S.A.) COMPARED TO XALATAN® (LATANOPROST 0.005% OPHTHALMIC SOLUTION, PFIZER) IN PATIENTS WITH OCULARHYPERTENSION OR PRIMARY OPEN ANGLE GLAUCOMA.Ocular hypertension and open angle glaucomaMedDRA version: 20.0Level: PTClassification code 10030043Term: Ocular hypertensionSystem Organ Class: 10015919 - Eye disordersMedDRA version: 20.0Level: PTClassification code 10030348Term: Open angle glaucomaSystem Organ Class: 10015919 - Eye disordersEUCTR2018-001727-39-HUPolpharma S.A.50
已完成
3 期
Phase III Investigator-Initiated Trial to Investigate Safety and Efficacy of Edoxaban in Patients with Chronic Thromboembolic Pulmonary HypertensioChronic Thromboembolic Pulmonary HypertensionCTEPH, DOAC, warfarinJPRN-jRCT2071200098Abe Kohtaro74