此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Study of AGN-190584 Eye Drops to Assess Safety and Efficacy in Participants Aged 40-80 Years With Pseudophakic Presbyopia (ARIES)

2022年6月24日 更新者：Allergan

A Phase 2, Multicenter, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety and Efficacy of AGN-190584 in Subjects With Pseudophakic Presbyopia

Presbyopia is a condition in which the eye exhibits a diminished ability to focus on near objects with increasing age. This study will assess the safety and exploratory efficacy of AGN-190584 is in treating participants with pseudophakic presbyopia.

AGN-190584 is approved (in the United States) for use in adults with presbyopia (including those who are pseudophakic) and this study is being conducted to better understand the safety and efficacy in the pseudophakic presbyopia population. This study is double-masked meaning that neither the participants nor the study doctors will know who will be given AGN-190584 and who will be given vehicle (does not contain treatment drug). Study doctors put the participants in 1 of the 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 3 chance that participants will be assigned to vehicle. Approximately 150 participants aged 40-80 years with pseudophakic presbyopia will be enrolled in approximately 30 sites in the US.

Participants will receive eye drops of AGN-190584 or vehicle once daily in the morning in each eye for 14 days.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study. The effect of the treatment will be evaluated by medical assessments, checking for side effects and completing questionnaires.

研究概览

地位

撤销

条件

干预/治疗

研究类型

介入性

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

  • 美国
    • Alabama
      • Dothan、Alabama、美国、36301
        • Trinity Research Group /ID# 243541
    • Arizona
      • Chandler、Arizona、美国、85224
        • Arizona Eye Center /ID# 243897
    • California
      • Glendale、California、美国、91204-2500
        • Global Research Management /ID# 243544
      • Inglewood、California、美国、90301
        • United Medical Research Institute /ID# 243531
      • Newport Beach、California、美国、92663-3600
        • Salvay Vision /ID# 243828
      • Newport Beach、California、美国、92663-3637
        • The Eye Research Foundation /ID# 243524
      • Sacramento、California、美国、95815
        • Sacramento Eye Consultants /ID# 243538
    • Florida
      • Crystal River、Florida、美国、34429
        • Nature Coast Clinical Research - Crystal River /ID# 243519
      • Delray Beach、Florida、美国、33484
        • Segal Drug Trials, Inc /ID# 243521
      • Fort Myers、Florida、美国、33901
        • Eye Associates of Fort Meyers /ID# 243545
      • Jacksonville、Florida、美国、32204
        • Levenson Eye Associates Inc. /ID# 243532
    • Georgia
      • Atlanta、Georgia、美国、30322-1013
        • Emory University /ID# 243534
      • Morrow、Georgia、美国、30260-4180
        • Clayton Eye Clinical Research, LLC /ID# 243530
      • Roswell、Georgia、美国、30076
        • Coastal Research Associates /ID# 243525
    • Kansas
      • Pittsburg、Kansas、美国、66762-2620
        • Kannarr Eye Care /ID# 243542
    • Kentucky
      • Edgewood、Kentucky、美国、41017-3415
        • Cincinnati Eye Institute- Edgewood /ID# 243810
      • Louisville、Kentucky、美国、40206-1738
        • The Eye Care Institute /ID# 243588
    • Michigan
      • Fraser、Michigan、美国、48026
        • Fraser Eye Center /ID# 244038
    • Missouri
      • Kansas City、Missouri、美国、64034
        • Silverstein Eye Centers /ID# 243546
    • New Jersey
      • Dover、New Jersey、美国、07801-1629
        • Eye Associates of North Jersey /ID# 243913
      • South Orange、New Jersey、美国、07079-1855
        • Northern New Jersey Eye Institute PA /ID# 243522
    • New York
      • Rochester、New York、美国、14618-2616
        • Rochester Ophthalmological Group PC /ID# 243539
    • Ohio
      • Powell、Ohio、美国、43065
        • EyeCare Professionals Inc /ID# 243938
    • Pennsylvania
      • Cranberry Township、Pennsylvania、美国、16066
        • Scott and Christie and Associates /ID# 243548
    • Tennessee
      • Maryville、Tennessee、美国、37805
        • University Eye Surgeons /ID# 243926
      • Smyrna、Tennessee、美国、37167
        • Advancing Vision Research /ID# 243529
    • Texas
      • Dallas、Texas、美国、75243
        • Key-Whitman Eye Center /ID# 243928
      • San Antonio、Texas、美国、78229
        • Eye associates /ID# 243526
      • San Antonio、Texas、美国、78229
        • Parkhurst Nuvision /ID# 244041
    • Utah
      • Draper、Utah、美国、84020-7133
        • Hoopes, Durrie, Rivera Research /ID# 243535
      • Ogden、Utah、美国、84403-2200
        • Country Hills Eye Center /ID# 243520
      • Saint George、Utah、美国、84790
        • Southern Utah Medical Research /ID# 243931

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

40年 至 80年 (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:

  • History of bilateral pseudophakia with monofocal intraocular lenses corrected for distance (noncomplicated cataract surgery), with identifiable intraocular lens type/brand, at least 3 months after surgery (prior to baseline), and be in stable condition.
  • If a participant has had neodymium-doped yttrium aluminum garnet (Nd:YAG) laser capsulotomy, it needs to be done bilaterally at least 1 month prior to baseline.
  • Subjective complaints of poor near vision that impacts activities of daily living, as defined by at least a moderate impact (score >= 3) on at least 1 question on 25-Item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) Questions 5 to 7 in the main questionnaire or Near Vision Subscale, Questions A3 to A5 in the Appendix of Optional Additional Questions at the screening visit.
  • Best distance correction at screening in the range of spherical -1.50 D to +1.00 D inclusively and cylinder <= ±2.00 D with photopic high contrast binocular corrected distance visual acuity (CDVA) of 20/25 or better at the screening and baseline visits.
  • Mesopic, high contrast binocular distance-corrected near visual acuity (DCNVA) no better than 20/40 (J3) at screening and baseline visits.

Exclusion Criteria:

- Presence of any ocular condition that, in the opinion of the investigator, could affect the safety of the participant or interpretation of efficacy parameters (e.g., uveitis, acute iritis, retinal detachment or retinal tear).

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：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：AGN-190584
Participants will receive one drop of AGN-190584 instilled in each eye once daily for 14 days.
药品：AGN-190584
Eye drops
安慰剂比较：Vehicle
Participants will receive one drop of vehicle instilled in each eye once daily for 14 days.
药品：Vehicle
Eye 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
Number of Participants Experiencing Adverse Events (AEs)
大体时间：Up to approximately 14 days
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.
Up to approximately 14 days

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

Allergan

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 (预期的)

2022年6月9日

初级完成 (预期的)

2023年4月4日

研究完成 (预期的)

2023年4月4日

研究注册日期

首次提交

2022年5月23日

首先提交符合 QC 标准的

2022年5月23日

首次发布 (实际的)

2022年5月26日

研究记录更新

最后更新发布 (实际的)

2022年6月29日

上次提交的符合 QC 标准的更新

2022年6月24日

最后验证

2022年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • M21-194

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

IPD 共享时间框架

For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

IPD 共享访问标准

Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

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.

订阅