Safety, Efficacy, Tolerability and Pharmacokinetics of AGN-223575 Ophthalmic Suspension in Patients With Dry Eye Disease
2019年3月15日 更新者：Allergan
This study will evaluate the safety, efficacy, tolerability, and systemic pharmacokinetics of 3 different doses of topical ophthalmic AGN-223575 suspension compared to AGN-223575 vehicle in patients with dry eye disease.
研究概览
研究类型
介入性
注册 (实际的)
236
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
-
-
Arizona
-
Phoenix、Arizona、美国、85003
- Arizona Center for Clinical Trials
-
-
California
-
Glendale、California、美国、91203
- Specialty Eye Ctr. Med. Group
-
Newport Beach、California、美国、92663
- The Eye Research Foundation
-
Santa Ana、California、美国、92705
- WCCT Global
-
-
Colorado
-
Colorado Springs、Colorado、美国、80909
- Eye Associates of Colorado Springs
-
-
Florida
-
Lecanto、Florida、美国、34491
- West Coast Eye Institute
-
-
Georgia
-
Morrow、Georgia、美国、30260
- Eye Care Centers Management, Inc.
-
Roswell、Georgia、美国、30076
- Coastal Research Assoc. LLC
-
-
Illinois
-
Hoffman Estates、Illinois、美国、60169
- Chicago Cornea Consultants
-
-
Kansas
-
Overland Park、Kansas、美国、66211
- Durrie Vision
-
-
Kentucky
-
Lexington、Kentucky、美国、40509
- Kentucky Center for Vision
-
-
Massachusetts
-
Boston、Massachusetts、美国、02111
- Tufts Medical Center/ Tufts University School of Medicine
-
-
Missouri
-
Kansas City、Missouri、美国、64154
- Moyes Eye Center
-
Saint Louis、Missouri、美国、63131
- Ophthalmology Associates
-
Washington、Missouri、美国、63090
- Comprehensive Eye Care Ltd.
-
-
New York
-
New York、New York、美国、10013
- Raymond Fong MD, PC
-
Wantagh、New York、美国、11793
- South Shore Eye Care LLP
-
-
North Carolina
-
Charlotte、North Carolina、美国、28210
- SE Clinical Research Associates, LLC/ Charolette Eye Ear Nose
-
High Point、North Carolina、美国、27262
- Cornerstone Eye Care
-
-
Ohio
-
Cincinnati、Ohio、美国、45236
- Eye Care Associates of Greater Cincinnati
-
-
Oregon
-
Portland、Oregon、美国、97210
- Mark A. Terry, MD PC/ Devers Eye Institute
-
-
South Carolina
-
Charleston、South Carolina、美国、29414
- Bluestein Custom Vision
-
Florence、South Carolina、美国、29501
- Carolinas Centers for Sight, PC
-
-
South Dakota
-
Rapid City、South Dakota、美国、57701
- Black Hills Regional Eye Institute
-
-
Texas
-
Austin、Texas、美国、78731
- Keystone Clinical Research
-
Houston、Texas、美国、77055
- Whitsett Vision Group
-
Houston、Texas、美国、77025
- Houston Eye Associates
-
San Antonio、Texas、美国、78240
- Medical Center Opth. Assoc.
-
-
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:
- Signs and symptoms of dry eye disease
- Has used RESTASIS and/or artificial tears in both eyes twice a day for at least 60 days.
Exclusion Criteria:
- History of glaucoma, or ocular hypertension
- Diagnosis of ocular infection
- Use of contact lenses in the past 14 days or expected use during the study
- Use of any topical ophthalmic medications in the past 30 days
- Use of corticosteroids in the past 30 days.
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：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：AGN-223575 Dose A
1 drop of AGN-223575 Dose A ophthalmic solution administered in each eye twice daily for 14 day followed by either 1 drop of AGN-223575 Dose A ophthalmic solution or 1 drop of vehicle to AGN-223575 in each eye once daily for 7 days.
|
AGN-223575 ophthalmic solution once or twice daily
Vehicle to AGN22375 ophthalmic solution once or twice daily.
|
|
实验性的：AGN-223575 Dose B
1 drop of AGN-223575 Dose B ophthalmic solution administered in each eye twice daily for 14 day followed by either 1 drop of AGN-223575 Dose B ophthalmic solution or 1 drop of vehicle to AGN-223575 in each eye once daily for 7 days.
|
AGN-223575 ophthalmic solution once or twice daily
Vehicle to AGN22375 ophthalmic solution once or twice daily.
|
|
实验性的：AGN-223575 Dose C
1 drop of AGN-223575 Dose C ophthalmic solution administered in each eye twice daily for 14 day followed by either 1 drop of AGN-223575 Dose C ophthalmic solution or 1 drop of vehicle to AGN-223575 in each eye once daily for 7 days.
|
AGN-223575 ophthalmic solution once or twice daily
Vehicle to AGN22375 ophthalmic solution once or twice daily.
|
|
安慰剂比较：AGN-223575 Vehicle
1 drop of Vehicle to AGN-223575 ophthalmic solution administered in each eye twice daily for 14 day followed by 1 drop of vehicle to AGN-223575 ophthalmic solution in each eye once daily for 7 days.
|
Vehicle to AGN22375 ophthalmic solution once or twice daily.
|
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 |
|---|---|---|
|
Change From Baseline in Conjunctival Redness Score in the Study Eye Using a 5-Point Scale
大体时间：Baseline, Day 14
|
Nasal and temporal bulbar conjunctival hyperemia were graded separately in each eye by the investigator under slit-lamp magnification by assigning a score of 0 to 4 for each quadrant based on comparison to the Allergan Dry Eye Redness Scale with photographic reference where: 0=Normal, vessels of bulbar conjunctiva are easily observed; 1=Trace redness; 2=Mild redness; 3=Moderate redness; 4=Severe redness, and each score is associated with a reference photo.
For each eye, the study quadrant was determined by the greater (more severe) of the baseline redness scores for nasal and temporal bulbar conjunctival hyperemia as assessed using the Allergan Dry Eye Redness Scale.
If the temporal score was greater than the nasal score, then the temporal quadrant was the study quadrant for the eye and was used to assess primary efficacy; otherwise the nasal quadrant was the study quadrant.
A negative change from baseline (less redness) indicates improvement.
|
Baseline, Day 14
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score Using a 5-Point Scale
大体时间：Baseline, Day 14
|
OSDI questionnaire consists of 12 questions regarding ocular symptoms, environmental triggers, and vision-related functioning in patients with dry eye disease.
The participants rate each question on a 5-point scale where: 0=none of the time to 4=all of the time.
The scores are totaled over the 12 questions and normalized/converted to a total score of 0=no disability to 100=complete disability.
Higher OSDI scores are associated with greater severity.
A negative change from Baseline indicates improvement.
|
Baseline, Day 14
|
|
Change From Baseline in Corneal Staining Score of the Study Eye Using a 6-Point Scale
大体时间：Baseline, Day 14
|
The cornea is the transparent front part of the eye which covers the iris and pupil.
Staining of the cornea following ocular administration of fluorescein dye was graded using a 6-point scale where: 0=no staining to 5=diffuse staining.
The higher the grade score, the worse the dry eye severity.
A negative change from Baseline indicates improvement.
|
Baseline, Day 14
|
|
Percentage of Participants With Complete Redness Response (Yes/No) in the Study Eye
大体时间：Day 14
|
A participant was considered a redness responder if the study quadrant redness score based on the Allergan Dry Eye Redness Scale in the study eye was 0=Normal (no redness).
|
Day 14
|
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
2015年6月1日
初级完成 (实际的)
2016年1月1日
研究完成 (实际的)
2016年1月1日
研究注册日期
首次提交
2015年5月1日
首先提交符合 QC 标准的
2015年5月1日
首次发布 (估计)
2015年5月6日
研究记录更新
最后更新发布 (实际的)
2019年4月5日
上次提交的符合 QC 标准的更新
2019年3月15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.