EUCTR2012-000026-22-ES进行中（未招募）1 期
Open, Observer-blind, two Parallel Group, Randomized, Multicentric Clinical Phase III Trial on the Comparison of Efficacy and Tolerability of a New Preservative-free Formulation of Travoprost 40 µg/ml Eye Drops vs. Travatan? Eye Drops in Patients with Primary Open Angle Glaucoma or Ocular Hypertension - QTM/OMN0112
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
- •?male or female patients, of any race and ?18 years of age;
- •?diagnosed of unilateral or bilateral primary open angle glaucoma or ocular hypertension;
- •?on treatment with an IOP-lowering prostaglandin analogue for at least 6 months;
- •?on treatment with an IOP ?21 mmHg on medication measured as a mean of both eyes at two measurements at least one hour apart;
- •?best-corrected visual acuity ?20 of 100 corresponding to logMAR of 0.7 in both eyes;
- •?in case of women, postmenopausal (>12 months without menstrual bleeding), surgically sterilized, or on use of effective birth control measures;
- •?expected by the investigator that IOP would remain controlled with the new treatment without optic nerve damage or progression of visual field loss;
- •?able to understand the requirements of the clinical trial and to agree to return for required follow-up visits;
- •?willing to provide voluntary written informed consent and data protection declaration before any clinical trial related procedure is performed.
- •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 170
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •?pre-treatment for primary open angle glaucoma or intraocular hypertension other than prostaglandin analogues;
- •?a history of chronic or recurrent inflammatory eye disease, ocular trauma or infections;
- •?narrow-angle/angle-closure glaucoma;
- •?clinically significant or progressive retinal disease;
- •?intraocular surgery within the past 6 months;
- •?ocular laser surgery within the past 3 months;
- •?a change in glaucoma therapy within 1 month before the screening visit;
- •?best-corrected visual acuity worse than 0.7 logarithm of minimal angle of resolution (logMAR) score, extremely narrow or partially closed angle, cup/disk ratio >0.8;
- •?history of bronchial asthma, or severe chronic obstructive pulmonary disease; reactive airway disease including bronchial asthma, a history of bronchial asthma, or severe chronic obstructive pulmonary disease.
- •?treatment with local or systemic corticosteroids;
- •?inability to discontinue the use of glucocorticoid medications;
- •?not receiving stable doses of any medication that could affect IOP for 30 days before the beginning of the clinical trial (e.g. clonidine);
研究者
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