Efficacy and Safety Study of FID 119515A
2018年5月31日 更新者：Alcon Research
A Randomized, Observer-Masked, Efficacy and Safety Study of FID 119515A in Dry Eye
The purpose of this study was to compare the effect of FID 119515A to Blink® Tears on the integrity of tear film in adults with a history of dry eye in both eyes.
研究概览
详细说明
Subjects who met the enrollment criteria were randomized in a 2:1 manner to receive treatment with FID 119515A or Blink® Tears respectively for this 1-day, single-dose study.
研究类型
介入性
注册 (实际的)
75
阶段
- 不适用
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:
- Sign Informed Consent.
- Best corrected visual acuity (BCVA) of 55 or greater in each eye as measured by an ETDRS chart (letters read method).
- At least a 3 month documented history of dry eye in both eyes.
- TBUT and Ocular Surface Disease Index (OSDI) Questionnaire score as specified in protocol.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Pregnant or breastfeeding.
- Any evidence of ocular infection or inflammation within 30 days prior to Screening.
- Any ocular surgery.
- Ocular trauma requiring medical or pharmacological treatment within 1 year of Screening.
- Current presence of punctal plugs (permanent or temporary) or previous permanent punctal closure by cautery/diathermy.
- Use of topical ocular prescription or non-prescription medications within 30 days of Screening.
- Participation in any other clinical trial within 30 days prior to Screening.
- Other protocol-defined exclusion criteria may apply.
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：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：FID 119515A
FID 119515A, 1 drop instilled in the study eye, single dose
|
topical ocular drops
|
|
有源比较器：Blink
Blink® Tears, 1 drop instilled in the study eye, single dose
|
topical ocular drops
|
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 |
|---|---|---|
|
Mean Change From Baseline in Tear Break-up Time (TBUT) at 60 Minutes
大体时间：Baseline, 60 minutes
|
Fluorescein dye was instilled in the eye to assess tear break-up time.
After instillation of the fluorescein, the subject was instructed to blink 3 times, then stare and not blink.
The investigator measured the time from the last blink until the first black (dry) spot appeared in the precorneal tear film.
Tear break-up time was assessed prior to test article instillation (baseline) and at 60 minutes.
Three consecutive measurements were taken per eye at each time point, with the average of the 3 scores being the value analyzed.
An increase in total score equates to improvement.
One eye was chosen as the study eye and only data for the study eye were used.
|
Baseline, 60 minutes
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Area Under Curve (AUC) of TBUT From 0 to 60 Minutes
大体时间：0 to 60 minutes
|
Fluorescein dye was instilled in the eye to assess tear break-up time.
After instillation of the fluorescein, the subject was instructed to blink 3 times, then stare and not blink.
The investigator measured the time from the last blink until the first black (dry) spot appeared in the precorneal tear film.
Tear break-up time was assessed prior to test article instillation (baseline) and at 5, 15, 30, and 60 minutes.
Three consecutive measurements were taken per eye at each time point, with the average of the 3 scores being the value analyzed.
An increase in total score equates to improvement.
One eye was chosen as the study eye and only data for the study eye were used.
|
0 to 60 minutes
|
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。
调查人员
- 研究主任：Lisa Lindsey, PhD、Alcon Research
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5月1日
初级完成 (实际的)
2013年6月1日
研究完成 (实际的)
2013年6月1日
研究注册日期
首次提交
2013年4月12日
首先提交符合 QC 标准的
2013年4月12日
首次发布 (估计)
2013年4月16日
研究记录更新
最后更新发布 (实际的)
2018年6月29日
上次提交的符合 QC 标准的更新
2018年5月31日
最后验证
2014年4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.
FID 119515A的临床试验
-
University of Southern CaliforniaNational Cancer Institute (NCI)招聘中
-
Alcon Research完全的