NCT01493271已完成2 期
An Adaptive, Multi-center, Randomized, Investigator-masked, Subject-masked, Multiple-dose, Placebo-controlled, Parallel Study to Investigate Efficacy, Safety, Tolerability and Pharmacokinetics of RO5093151 for up to 28 Days in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 31
- 主要终点
- Change in mean intraocular pressure (IOP) at 1 hour post-dose following 7 days of treatment
研究概览
简要总结
This randomized, double-blind, placebo-controlled, multi-center study will evaluate the safety and the effect of RO5093151 on intraocular pressure in patients with ocular hypertension or open angle glaucoma. Patients will be randomized to receive oral doses of RO5093151 or placebo twice daily. The anticipated time on study treatment is 7 days with the possibility to extend to 28 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients, at least 21 years of age, inclusive
- •Diagnosis of ocular hypertension or primary open angle glaucoma in at least one eye
- •Able to participate and willing to give informed consent
排除标准
- •Presence of extreme narrow angle with complete or partial closure
- •Progressive retinal or optic nerve disease from any cause other than glaucoma
- •History or signs of penetrating ocular trauma
- •Uncontrolled hypertension
- •Clinically significant abnormalities in laboratory test results
- •Positive test results on hepatitis B, hepatitis C, or HIV 1 and 2
- •Kidney disease or dysfunction
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
RO5093151
Experimental
干预措施: RO5093151 (Drug)
结局指标
主要结局
Change in mean intraocular pressure (IOP) at 1 hour post-dose following 7 days of treatment
时间窗: Day 7
次要结局
- Pharmacokinetics (area under the concentration time curve)(Day 7)
- Change in mean daily intraocular pressure (IOP)(Up to 28 days)
- Change in mean intraocular pressure (IOP) at each assessment time-points(Up to 28 days)
- Change in intraocular pressure (IOP) during a placebo lead-in phase(7 days)
- Urinary ratio of tetrahydrocortisol to tetrahydrocortisone(7 days)
- Safety (incidence of adverse events)(Up to 28 days)
研究者
相似试验
已完成
1 期
A Study of RO5095932 in Patients With Type 2 Diabetes MellitusDiabetes Mellitus Type 2NCT00961909Hoffmann-La Roche122
已完成
3 期
Adaptive COVID-19 Treatment Trial (ACTT)COVID-19NCT04280705National Institute of Allergy and Infectious Diseases (NIAID)1,062
撤回
2 期
A Study of RO5036505 in Patients With Moderate to Severe AsthmaAsthmaNCT00967590Hoffmann-La Roche
终止
1 期
A Study Evaluating the Safety of Tocilizumab in Addition to Standard of Care Premedication Given Before Obinutuzumab + Chlorambucil in Participants With Untreated B-Cell Chronic Lymphocytic Leukemia (B-CLL) and ComorbiditiesB-Cell Chronic Lymphocytic LeukemiaNCT02336048Hoffmann-La Roche38
已完成
1 期
A Study of RO5310074 in Patients With Psoriatic ArthritisArthritis, PsoriaticNCT01199809Hoffmann-La Roche19