EUCTR2016-000176-20-DE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
- 134
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 morning or 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) = 19 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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