EUCTR2006-003907-38-GB进行中（未招募）不适用
A Multi-Centre, Double-Blind, Randomised, Parallel-Group, Placebo Controlled Phase II Study to Investigate the Safety, Efficacy, and Pharmacokinetic Profile of Twice-daily DNB-001 in Previously Untreated Patients with Intraocular Hypertension
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
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.Male or female, at least 18 years of age
- •2.Patients with ocular hypertension in both eyes
- •3.Best corrected ETDRS visual acuity score equivalent to a Snellen score of 20/50 or better in each eye
- •4.Written informed consent prior to any study procedure
- •5.Ability and willingness to follow study instructions and likely to complete all study visits
- •6. Screening (day -30 ~ -1) negative urine pregnancy test for all female patients prior to entry into the study, unless they are postmenopausal for at least one year and/or hysterectomised and/or have a documented medical history of clinical inability to become pregnant.
- •7.Screening (day -30 ~ -1) IOP higher or equal to 21 mm Hg and = 29 mm Hg in each eye
- •8.Body mass index (BMI) between 18.5 and 30 kg/m²
- •9.Patients who are healthy as determined by pre-study medical history, physical examination and the absence of protocol-specified ECG abnormalities on the Visit 1 ECG
- •10.Patients who had clinical laboratory tests within the reference ranges or clinically acceptable to the investigator
- •11.Subjects who are negative for hepatitis B surface antigen (HBsAg) and hepatitis C antibody
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Prior diagnosis of glaucoma of any type
- •2.Subjects with uncontrolled systemic disease of any type. Patients receiving insulin for diabetes mellitus will not be admitted to the study
- •3.All female patients of childbearing potential. Participating females need to be postmenopausal for at least one year and/or hysterectomised and/or need to have a documented medical history of clinical inability to become pregnant. Male patients have to use barrier contraception (condoms plus spermicidal jelly) during the study or have to be surgically sterile
- •4.Use of any ocular anti-hypertensive medication, topical or systemic in the past 3 months from screening date
- •5.Known allergy or sensitivity to the study medications
- •6.Anticipated alteration in chronic therapy with or introduction of agents known to have a substantial effect on IOP (e.g. beta-adrenergic blocking agents)
- •7. Corneal abnormalities that would interfere with accurate IOP readings with an applanation tonometer
- •8.Use of oral, injectable or topical ophthalmic steroid within the past 21 days from screening date
- •9. History of ocular allergy
- •10. Any active ocular disease (e.g. uveitis, ocular infection, severe dry eye). Patients may have cataracts, age-related macular degeneration or background diabetic retinopathy if, in the opinion of the Investigator, it would not interfere with the conduct of the study
- •11. Required use of ocular medication (including artificial tears) during the study
- •12. Significant visual field loss or progressive field loss during the past year.
- •13. Significant optic nerve abnormality in the opinion of the Investigator as determined by ophthalmoscopy
- •14. Presence of optic nerve head haemorrhage
- •15. Gonioscopy consistent with potential angle closure glaucoma
- •16. Intraocular surgery within the past 6 months from screening date
- •17. Past history of any laser or filtering surgery for glaucoma
- •18. Refractive surgery of any type within the past 3 months from screening date
- •19. Inability to visualise the patient’s optic nerve
- •20. Any abnormal lab values at Screening related to liver function (e.g. aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase [ALP] or bilirubin)
- •21. Anticipated change in dosage of or introduction of new medications for chronic cardiac, pulmonary or hypertensive conditions
- •22. Anticipated change in over-the-counter medications, vitamins or herbal products during the course of the study
- •23. Use of acetaminophen (paracetamol) during the study
- •24. Current enrolment in an investigational drug or device study or participation in such a study within 30 days of screening
- •25. History of drug or alcohol abuse within the past one year
- •26. Patient has any condition or situation that, in the Investigator’s opinion, might confound the results of the study, may put the patient at significant risk or might interfere with the patient’s ability to participate in the study.
研究者
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