EUCTR2005-002574-29-FI进行中（未招募）1 期
Pharmacodynamics of tafluprost 0.0015% eye drops: a comparison between the preserved and unpreserved formulation in patients with open-angle glaucoma or ocular hypertension.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Santen Oy
- 入组人数
- 40
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
- •- Aged 18 years or more
- •- A diagnosis of open-angle glaucoma (primary open-angle glaucoma, capsular glaucoma or pigmentary glaucoma) or ocular hypertension
- •- Prior use of prostaglandin(s) and a known positive treatment response to PGs (a 15% reduction in IOP confirmed in anamnesis)
- •- An untreated (after washout) IOP of 22-34 mmHg in at least one eye at the 8:00 measurement at baseline (Visit 2)
- •- A best corrected ETDRS visual acuity score of +0.6 logMAR or better in each eye
- •- Willing to follow instructions and a written informed consent
- •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
- •- Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception
- •- Previous participation in any clinical trial in which tafluprost was an investigational drug
- •- Any uncontrolled systemic disease (e.g., hypertension, diabetes)
- •- Filtration surgery or any other ocular (including ocular laser procedures) surgery within 6 months prior to Visit 1 (screening) in either eye
- •- Change of an existing chronic therapy that could substantially effect the IOP or the study outcomes within 30 days prior to Visit 1 (screening), or anticipated change in such therapy during the study
- •- IOP greater than 34 mmHg at any time point in any eye at Visit 2 (baseline)
- •- Known allergy or hypersensitivity to the study medications or their components, including benzalkonium chloride (BAK)
- •- Use of contact lenses at Visit 1 (screening) or during the study
- •- Any active external ocular disease, inflammation, or infection of the eye and/or eyelids within 3 months from the Screening visit
- •- Any ocular, systemic or psychiatric disease/condition that in the opinion of the investigator may put the patient at a significant risk or may confound the study results or may interefere significantly with the patient’s participation in the study
- •- Any corneal abnormality or other condition preventing reliable applanation tonometry
- •- Anterior chamber angle less than grade 2 according to Schaffer classification as measured by gonioscopy
- •- Advanced visual field defect or a visual field defect that is anticipated to progress during the study period
研究者
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