EUCTR2011-003851-20-SE进行中（未招募）不适用
A Multicente, Observer-Masked Study of the Safety and Efficacy of MDPF Travoprost, 0.004% Compared to TRAVATAN in Patients with Open-Angle Glaucoma or Ocular Hypertension - Travoprost MDPF 3 Month Safety and Efficacy Study
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 720
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
- •Patients 18 yrs or older
- •Diagnosis of Open-Angle glaucoma
- •Qualifying mean IOP at the eligibility visits
- •Able to understand and sign an informed consent form
- •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 720
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Women of childbearing potential (ie, those who are not postmenopausal for at least 1 year or surgically sterile) are excluded from participation if they are currently pregnant,have a positive result on the urine pregnancy test at Screening, or intend to become pregnant during the study period; are breast-feeding; or are not in agreement to use adequate birth control methods to prevent pregnancy
- •2. Modified Shaffer angle Grade < 2 as measured by
- •gonioscopy (extreme narrow angle with complete or
- •partial closure).
- •3. Cup/disc ratio (C/D) greater than 0.80 (horizontal or
- •vertical measurement).
- •4. Severe central visual field loss defined as a sensitivity
- •= 10 dB in at least 2 of the 4 visual field test points closest
- •to the point of fixation.
- •5. Patients who in the opinion of the Investigator cannot
- •safely undergo the initial wash-out period discontinuing all
- •IOP-lowering ocular medication(s) for a minimum of 4 to
- •27 days prior to the E1 Visit.
研究者
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