An Open-label Extension Study to Evaluate the Safety of the 13 mg Bimatoprost Ocular Insert (OLE2)
2019年3月26日 更新者：ForSight Vision5, Inc.
An Open-label Extension (OLE 2) Study to Evaluate the Safety of the 13 mg Bimatoprost Ocular Insert in Subjects With Open-angle Glaucoma or Ocular Hypertension Who Have Completed Study FSV5-004
This study evaluated the long-term (9-months) safety of the Bimatoprost Ocular Insert in participants with Glaucoma or Ocular Hypertension who completed study FSV5-004.
All the participants received Bimatoprost Ocular Insert and wore it for approximately 3 months (12 weeks), then had that Insert removed and a new Insert placed for another 26 weeks (approximately 6 months).
研究概览
研究类型
介入性
注册 (实际的)
81
阶段
- 阶段2
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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Arkansas
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Fayetteville、Arkansas、美国、72704
- Vold Vision
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California
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Artesia、California、美国、90701
- Sall Medical Research Center
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Newport Beach、California、美国、92663
- Eye Research Foundation
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Georgia
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Morrow、Georgia、美国、30260
- Clayton Eye Center
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North Carolina
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Charlotte、North Carolina、美国、28204
- Mundorf Eye Center
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High Point、North Carolina、美国、27262
- Cornerstone Health Care; Cornerstone Eye Care
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Tennessee
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Maryville、Tennessee、美国、37803
- University Eye Specialists
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Memphis、Tennessee、美国、38119
- Total Eye Care
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Texas
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San Antonio、Texas、美国、78229
- R&R Eye Research, LLC
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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
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Completed FSV5-004 study.
- Written informed consent prior to any study procedure.
- Willingness to comply with the visit schedule.
Key Exclusion Criteria:
- Participation in an investigational drug or device study other than FSV5-004 within the past 6 months or anticipated participation during the study period.
- Subjects who will require contact lens use during the study period.
- Any condition or situation (such as uncontrolled systemic disease) that, in the Investigator's opinion, might confound the results of the study, may put the subject at significant risk or might interfere with the subject's ability to participate in the study.
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：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：13 mg Bimatoprost Ocular Insert
13 mg Bimatoprost Ocular Insert in each eye used continuously for 12 weeks, then replaced with a new 13 mg Bimatoprost Ocular Insert in each eye used continuously for another 26 weeks.
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Bimatoprost Ocular Insert in each eye used continuously for 12 weeks, then replaced with a new Bimatoprost Ocular Insert in each eye used continuously for another 26 weeks.
其他名称：
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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 |
|---|---|---|
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Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity
大体时间：Baseline (Day 0, enrollment in this study) to end of study (Week 38)
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An AE was defined as any untoward medical occurrence (eg, sign, symptom, disease, syndrome, intercurrent illness) that occurred in a study participant, regardless of the suspected cause during the study.
An ocular AE is an AE that occurred in the eye and non-ocular is an AE that occurred not in the eye.
The investigator assessed the worst severity of each AE as: Mild=aware of sign or symptom, but readily tolerated, Moderate=discomfort enough to cause interference with usual activity or Severe=incapacitating with inability to work or do usual activity.
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Baseline (Day 0, enrollment in this study) to end of study (Week 38)
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change From Baseline in Intraocular Pressure (IOP)
大体时间：Baseline (Day 0 in study FSV5-004) to Weeks 4, 8, 12, 24 and 38
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IOP is a measurement of the fluid pressure inside the eye.
IOP measurements were taken at 8 am (Time (T)=0 hour) at Weeks 4, 8, 12, 24 and 38.
Diurnal IOP measurements were also taken at 10 am (T=2 hour), and 4 pm (T=8 hour) at Weeks 12, 24 and 38.
IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint.
A negative change from Baseline indicated an improvement.
Baseline is defined as the IOP assessment done at the Randomization visit (Day 0) of study FSV5-004.
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Baseline (Day 0 in study FSV5-004) to Weeks 4, 8, 12, 24 and 38
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Percentage of Participants by Subject-Reported Comfort Assessment Categories
大体时间：Baseline (Day 0, enrollment in this study) Weeks 4, 8, 12, 24 and 38
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The participant assessed their overall comfort with ocular inserts using the following rating choices: Not aware of inserts, very comfortable; Aware of inserts, and comfortable; Tolerable, but mild discomfort; Moderate discomfort or Severe discomfort.
The percentage of participants in each rating category is reported.
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Baseline (Day 0, enrollment in this study) Weeks 4, 8, 12, 24 and 38
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Bimatoprost Ocular Insert Retention Duration
大体时间：Baseline (Day 0, enrollment in this study) to the end of study (Week 38)
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Insert duration was defined as the total duration (in days) that any ocular insert remained in place for each subject, measured from the date of Insert removal minus date of Insert placement + 1.
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Baseline (Day 0, enrollment in this study) to the end of study (Week 38)
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Percentage of Participants Who Received Rescue Treatment
大体时间：Baseline (Day 0, enrollment in this study) to the end of study (Week 38)
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Rescue treatment with topical bimatoprost was available for each eye if deemed necessary by the investigator to achieve desired IOP.
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Baseline (Day 0, enrollment in this study) to the end of study (Week 38)
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Change From Baseline in Endothelial Cell Count
大体时间：Baseline (Day 0, enrollment in this study) to end of study (Week 38)
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Density (number of cells/mm^2) of corneal endothelial cells was determined at four sites using specular microscopy of the central corneal endothelium at Baseline and at Week 38.
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Baseline (Day 0, enrollment in this study) to end of study (Week 38)
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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。
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 (实际的)
2015年8月10日
初级完成 (实际的)
2016年8月11日
研究完成 (实际的)
2016年8月11日
研究注册日期
首次提交
2015年8月27日
首先提交符合 QC 标准的
2015年8月28日
首次发布 (估计)
2015年9月1日
研究记录更新
最后更新发布 (实际的)
2019年4月2日
上次提交的符合 QC 标准的更新
2019年3月26日
最后验证
2019年3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.