NCT01284309已完成1 期
A Phase 1b, Randomized, Double-Masked, Parallel Group, Placebo Controlled Study to Assess Intraocular Pressure and Ocular Safety of the Beta-3 Agonist Mirabegron in Research Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 321
- 试验地点
- 1
- 主要终点
- Change from baseline to Day 56 in subject-average intraocular pressure (IOP)
研究概览
简要总结
The purpose of this study is to assess the affect of mirabegron on intraocular pressure (IOP) in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Female subject must be either post-menopausal (defined as at least 2 years without menses) or surgically sterile (at least 1 month) or of childbearing potential with contraception. All women of childbearing potential will be required to use contraception consisting of two forms of birth control (one of which must be a barrier method), must not be lactating, and must not be breastfeeding during the study period and for 30 days after final study drug administration. All women of childbearing potential must have a negative urine pregnancy test
- •Male subject with female spouses/partners who are of childbearing potential must use contraception consisting of two forms of birth control (one of which must be a barrier method) during the study period
- •Subject may either be otherwise healthy or have symptoms of overactive bladder by self-report
排除标准
- •History of glaucoma or ocular hypertension
- •Abnormal visual field in either eye
- •Ophthalmic condition that would interfere with reliable Goldmann tonometry (e.g., corneal edema, uveitis, severe keratoconjunctivitis sicca)
- •History of major ocular infection, inflammation, or herpes simplex keratitis; evidence of current clinically significant blepharitis or conjunctivitis
- •Any history of ocular surgery including refractive surgery such as laser-assisted in situ keratomileusis (LASIK) or photorefractive keratectomy (PRK) in any eye
- •Ocular trauma within the past six months
- •Severe myopia
- •Diabetes, Type I or Type 2, with or without medical management
- •Cardiovascular disease requiring pharmacotherapy
- •History of any type of dysrhythmia
- •Systemic hypertension requiring pharmacotherapy
- •Past diagnosis of any connective tissue or autoimmune disease including rheumatoid arthritis and spondyloarthropathies
- •History of psychiatric illness requiring hospitalization
- •Recent history (within past 24 months) of alcohol or other substance abuse (with the exception of nicotine)
- •Used tobacco-containing products or nicotine-containing products within past 3 months
- •Has been part of any clinical study past within 30 days or currently taking part in a clinical study other than the present study, or has participated in any previous study with mirabegron at any time
- •Ocular medication of any kind within past 30 days
研究组 & 干预措施
Mirabegron
Experimental
干预措施: Mirabegron (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline to Day 56 in subject-average intraocular pressure (IOP)
时间窗: Baseline and Day 56
Day 56 data will include subjects who discontinue early due to elevated IOP
次要结局
- Change from baseline to Day 10 in subject-average IOP(Baseline and Day 10)
- Number of subjects experiencing increase from baseline in a single-eye IOP by ≥6mmHg in either eye at Day 10(Baseline and Day 10)
- Number of subjects experiencing increase from baseline in a single-eye IOP by ≥6mmHg in either eye at Day 56(Baseline and Day 56)
- Number of subjects experiencing increase from baseline in a single-eye IOP by≥10 mmHg in either eye at Day 10(Baseline and Day 10)
- Number of subjects experiencing increase from baseline in a single-eye IOP by ≥10 mmHg in either eye at Day 56(Baseline and Day 56)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
A Study of DE-111A on the Treatment of Open Angle Glaucoma or Ocular HypertensionOpen-angle Glaucoma, Ocular HypertensionNCT03822559Santen Pharmaceutical Co., Ltd.219
已完成
4 期
Travoprost 0.004% Versus Pilocarpine 1% in Patients With Chronic Angle Closure Glaucoma (CACG)Angle-closure GlaucomaNCT00762645Alcon Research30
已完成
3 期
A Study Assessing the Safety and Efficacy of DE-117 in Subjects With POAG or OH Who Are Non-/Low-responders to Latanoprost: FUJI StudyPrimary Open Angle Glaucoma or Ocular HypertensionNCT02822742Santen Pharmaceutical Co., Ltd.26
已完成
2 期
A Study Comparing The Efficacy, Safety And Tolerability Of Latanoprost 75, 100 And 125 ug/ml To Xalatan In The Treatment Of Primary Open-Angle Glaucoma And Ocular HypertensionPrimary Open Angle GlaucomaOcular HypertensionNCT01379144Pfizer's Upjohn has merged with Mylan to form Viatris Inc.282
已完成
1 期
Study Evaluating the Safety and Intraocular Pressure (IOP) Lowering Response of Brimonidine Tartrate Ophthalmic Solution in Subjects With Open Angle Glaucoma or Ocular HypertensionGlaucoma and Ocular HypertensionNCT01687426Eye Therapies, LLC15