EUCTR2018-001727-39-HU进行中（未招募）1 期
A PHASE III, MULTICENTRE, RANDOMISED, INVESTIGATOR-MASKED, CROSSOVER,COMPARATIVE, NON-INFERIORITY TRIAL EVALUATING THE EFFICACYAND 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.
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
- 50
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
- •INCLUSION CRITERIA
- •A patient is eligible for inclusion in this study if all of the following criteria apply.
- •5.2.1.1 Inclusion Criteria
- •1. Male or female patients, 18-75 years old.
- •2. Provision of signed and dated Informed Consent.
- •3. General health conditions not interfering with participation in the study e.g.
- •blood pressure, pulse rate at screening as assessed by the investigator.
- •4. A female patient meeting one of the following criteria:
- •4.1. Participant is of childbearing potential and agrees to use one of the accepted
- •contraceptive regimens from at least 28 days prior to the first study drug
- •administration through to at least 30 days after the last dose of the study drug. An
- •acceptable method of contraception includes one of the following:
- •? Abstinence from heterosexual intercourse;
- •? Systemic contraceptives (combined birth control pills,
- •injectable/implant/insertable hormonal birth control products, transdermal
- •? Intrauterine device (IUD) (with or without hormones);
- •? Male condom with spermicide or male condom with a vaginal spermicide (gel,
- •foam, or suppository);
- •? Male partner vasectomized at least 6 months prior to the first study drug
- •administration;
- •4.2. Participant whose partner has had a vasectomy less than 6 months prior to dosing,
- •and agrees to use an additional acceptable method of contraception from the first
- •study drug administration through to at least 30 days after the last dose of the study
- •4.3. Participant is of non-childbearing potential, defined as surgically sterile (i.e. has
- •undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation) or is
- •in a postmenopausal state (i.e. at least 1 year without menses prior to the first study
- •drug administration).
- •5. Ocular hypertension or primary open angle glaucoma in at least one eye: mean diurnal
- •IOP measured at -12, -8, –4, 0 hours pre-treatment on Day 1 must be higher than or
- •equal to 22 mmHg, and lower than or equal to 34 mmHg (naïve or untreated, i.e. after
- •washout). The eye with the higher IOP will be selected as the study eye. If both eyes
- •have the same IOP, the right eye will be selected.
- •6. Not on any ophthalmic pressure-lowering medication, or able to be withdrawn from
- •current pressure-lowering medications for the washout periods as defined in this
- •clinical trial protocol.
- •7. No ocular trauma, surgery, inflammation or infection, no corneal foreign body in
- •the previous 3 months.
- •8. No clinically significant or progressive retinal disease as determined by dilated
- •peripheral retinal examination done at screening.
- •9. No concomitant use of any topical ophthalmic medication other than artificial tears.
- •10. No ocular glucocorticoids in the previous 3 months.
- •11. Within the previous 30 days prior to the first dose (visit 1) no systemic medication
- •that may alter IOP (e.g. beta blockers, calcium channel blockers, ACE inhibitors,
- •prostaglandins, etc.) unless the current treatment with these medicinal products
- •continues on a stable regimen for the duration of the study.
- •12. Patients may be contact lens wearers but must remove their contact lenses prior to
- •each drug application and keep them removed for a minimum of 15 minutes after
- •drug application. In addition, contact lenses must remain removed for a minimum of
- •20 minutes when ocular discomfort assessments are required. Contact lenses cannot
- •be worn on the days of visits to the clinic.
- 另有 3 项未显示
排除标准
- •Exclusion Criteria
- •1. Corrected visual acuity of less than distance Snellen 20/100 corresponding to decimal 0.20
- •or logMAR 0.70 in both eyes.
- •2. Evidence of acute ocular infection, corneal foreign body, or ocular inflammation within 3
- •months of the screening visit.
- •3. History or evidence of severe inflammatory eye disease (i.e. uveitis, retinitis, scleritis,
- •iritis) in one or both eyes
- •4. Previous significant ocular trauma, laser or incisional surgery within 3 months of the
- •screening visit including cataract surgery.
- •5. Traumatic cataract surgery with an open posterior capsule or any patient with an anterior
- •chamber intraocular lens implant or aphakia
- •6. IOP in either eye greater than 34 mmHg at Day 1 (mean diurnal IOP measured at -12, -8, –
- •4, 0 hours pre-treatment)
- •7. Any corneal abnormalities preventing reliable applanation tonometry.
- •8. Patients at risk of angle closure or evidence of acute, intermittent or chronic angle closure.
- •9. Patients with forms of glaucoma resulting from conditions other than primary open angle
- •glaucoma, such as pigmentary or pseudo-exfoliative glaucoma, open angle glaucoma of
- •pseudophakic patients, neovascular glaucoma.
- •10. Pupil with inadequate ability to dilate sufficiently for peripheral retinal examination.
- •11. History or evidence of Herpes simplex keratitis.
- •12. Patients with known risk factors for macular edema.
- •13. Pregnant or nursing women or women who intend to become pregnant during the trial.
- •14. Patients who have participated in another research study for an investigational product or
- •investigational medical device within 30 days of the screening visit.
- •15. History of drug or alcohol abuse within the last 6 months.
- •16. A history of hypersensitivity to latanoprost, or any component in the formulation of the
- •products being tested.
- •17. History of evidence of any medical condition that would, in the opinion of the investigator,
- •make the patient unsuitable for the study (i.e. severe hepatic, cardiovascular or renal
- •impairment).
- •18. 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.) if
- •the treatment regimen with these medicinal products is change during the study.
研究者
相似试验
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-HUAZAD Pharma AG66
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
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