EUCTR2016-000176-20-BE进行中（未招募）1 期
Safety and Efficacy with Twice Daily Brinzolamide 1% / Brimonidine 0.2% (SIMBRINZA) as an Adjunctive Therapy to Travoprost 0.004% / Timolol 0.5% (DUOTRAV) - Safety and Efficacy of Simbrinza as an Adjunctive to DuoTrav
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
- 240
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
- •- Diagnosis of open-angle glaucoma (including pseudoexfoliation or pigment dispersion glaucoma) or ocular hypertension
- •- Currently on treatment with Travoprost 0.004%fTimolol 0.5% prescribed as approved in the country, on evening dosing for at least 28 days prior to screening, and In the opinion of the Investigator may benefit from further lOP lowering
- •- Mean lOP measurements at both the Eligibility 1 and Eligibility 2 visits, in at least 1 eye (the same eye(s) = 21 and = 28 mmHg at 9:00 while on a Travoprost 0.004%/ Timolol 0.5% solution)
- •- Able to understand and sign an informed consent form that has been approved by an Institutional Review Board/Ethics Committee
- •- Willing and able to attend all study visits
- •- Other protocol-defined inclusion criteria may apply
- •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 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 150
排除标准
- •- Women of childbearing potential: not postmenopausal for at least 1 year or less than 6 weeks since sterilization, currently pregnant; have a positive result on the urine pregnancy test at Screening; intend to become pregnant during the study period; breast-feeding; or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
- •- Any form of glaucoma other than open-angle glaucoma or ocular hypertension
- •- Severe central visual field loss in either eye
- •- Chronic, recurrent or severe Inflammatory eye disease In either eye
- •- Ocular trauma in either eye within the past 6 months prior to the Screening visit
- •- Ocular infection or ocular inflammation in either eye within the past 3 months prior to the Screening visit
- •- Retinal degeneration, diabetic retinopathy, or retinal detachment in either eye
- •- Best-corrected visual acuity score worse than 55 ETDRS letters (equivalent to approximately 20/80 Snellen, 0.60 logMAR or 0.25 decimal) in either eye
- •- Other ocular pathology (including severe dry eye) in either eye that may, in the opinion of the Investigator, preclude the safe administration of any study medication
- •- Intraocular surgery in either eye within the past 6 months prior to the Screening visit
- •- Ocular laser surgery in either eye within the past 3 months prior to the Screening visit
- •- Any other condition including severe illness which would make the subject, in the opinion of the Investigator, unsuitable for the study
- •- Asthma, history of asthma, or severe chronic obstructive pulmonary disease
- •- Other protocol-defined exclusion criteria may apply
研究者
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