A Single Centre Study to Evaluate 3 Ophthalmic Formulations in Healthy Subjects
2014年5月1日 更新者:Amakem, NV
A Single Centre, Placebo-Controlled, Double-Masked, Sequential Designed Study to Evaluate 3 Ophthalmic Formulations of AMA0076 in Healthy Subjects
A Single Centre, Placebo-Controlled, Double-Masked, Sequential Designed Study to Evaluate 3 Ophthalmic Formulations of AMA0076 in Healthy Subjects
研究概览
详细说明
Each subject will receive the following treatments:
- Period 1: Formulation A (n = 14) or placebo (n = 7) twice daily for 7 days
- Period 2: Formulation B (n = 14) or placebo (n = 7) twice daily for 7 days
- Period 3: Formulation C (n = 14) or placebo (n = 7) twice daily for 7 days
There will be a minimum washout of 7 days between each treatment period (last dose of previous period to first dose of subsequent period
研究类型
介入性
注册 (实际的)
21
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Nottingham
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Ruddington、Nottingham、英国、NG11 6GS
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
35年 至 65年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Healthy males and non-pregnant, non-lactating females, aged 35 to 65 years.
- Body mass index of ≤35kg/m2.
- IOP between 15 and 24 mmHg (inclusive) in both eyes at Screening Visits 1 and 2.
Exclusion Criteria:
- Women of child-bearing potential who have a positive pregnancy test.
- Any subject deemed by the investigator to have uncontrolled systemic hypertension
- Use of systemic, inhaled or ocular corticosteroid treatment within 90 days of screening or likely to require their use during the study period.
- Any screening laboratory abnormality that, in either the investigator's or the medical monitor's judgment, is considered to be clinically significant or a safety risk.
- History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results of the subject's ability to participate in the study, or interfere with interpretation of the subject's study results.
- Participation in any other clinical study within 1 month of screening or during the study.
- Receipt of another investigational drug within 90 days of dosing in this study
- Diagnosis of any form of glaucoma.
- IOP >24 mmHg in either eye at any screening visit.
- Use of any ocular drops (including lubricating drops/artificial tears) during screening period or need for ocular drops during duration of study participation.
- In the opinion of the investigator, clinically significant eye trauma within 6 months of screening.
- Any intraocular ophthalmic procedure within 6 months of screening.
- Any ocular inflammation within 90 days of screening or a history of recurrent uveitis in either eye.
- Subjects with any known ocular disease and who are under care of a hospital ophthalmologist.
- Any condition preventing valid applanation tonometry measurement.
- Unable to discontinue contact lens wear during the study
- Visual acuity (VA) worse than 20/80 in either eye
- Subjects who are study site employees, or immediate family members of a study site or sponsor employee.
- History of any drug or alcohol abuse in the past 2 years.
- Regular alcohol consumption.
- Positive drugs of abuse test result.
- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
- Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
- Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hayfever is allowed unless it is active.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:AMA0076 Formulation A
Topical Ocular Drop BID X 1 wk
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实验性的:AMA0076 Formulation B
Topical Ocular Drop BID X 1wk
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实验性的:AMA0076 Formulation C
Topical Ocular Drop BID X 1 wk
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安慰剂比较:Placebo
Topical Ocular Drop BID X 1 wk
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Intraocular Pressure
大体时间:7 days
|
The primary endpoint is the comparison of Intraocular Pressure assessments taken at pre-treatment on Day -1 and on Day 7 for each diurnal time point (0, 2, 4 and 8 h post-anticipated dose [Day -1] or post-dose [Day 7]) for each treatment period between active treatment and placebo.
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7 days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Safety and Tolerability
大体时间:7 days
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The secondary endpoints are:
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7 days
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2013年9月1日
初级完成 (实际的)
2013年12月1日
研究完成 (实际的)
2013年12月1日
研究注册日期
首次提交
2013年12月2日
首先提交符合 QC 标准的
2013年12月5日
首次发布 (估计)
2013年12月6日
研究记录更新
最后更新发布 (估计)
2014年5月2日
上次提交的符合 QC 标准的更新
2014年5月1日
最后验证
2014年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
安慰剂的临床试验
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Mila (bMotion Technologies)完全的
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Universidad Autonoma de MadridCentro Universitario La Salle完全的