Study Stopped
Business Decision
Study of AGN-190584 Eye Drops to Assess Safety and Efficacy in Participants Aged 40-80 Years With Pseudophakic Presbyopia
ARIES
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
1 other identifier
interventional
N/A
1 country
32
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 2022
Shorter than P25 for phase_2
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2022
CompletedFirst Posted
Study publicly available on registry
May 26, 2022
CompletedStudy Start
First participant enrolled
June 9, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 4, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 4, 2023
CompletedJune 29, 2022
June 1, 2022
10 months
May 23, 2022
June 24, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants Experiencing Adverse Events (AEs)
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
Study Arms (2)
AGN-190584
EXPERIMENTALParticipants will receive one drop of AGN-190584 instilled in each eye once daily for 14 days.
Vehicle
PLACEBO COMPARATORParticipants will receive one drop of vehicle instilled in each eye once daily for 14 days.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- \- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (32)
Trinity Research Group /ID# 243541
Dothan, Alabama, 36301, United States
Arizona Eye Center /ID# 243897
Chandler, Arizona, 85224, United States
Global Research Management /ID# 243544
Glendale, California, 91204-2500, United States
United Medical Research Institute /ID# 243531
Inglewood, California, 90301, United States
Salvay Vision /ID# 243828
Newport Beach, California, 92663-3600, United States
The Eye Research Foundation /ID# 243524
Newport Beach, California, 92663-3637, United States
Sacramento Eye Consultants /ID# 243538
Sacramento, California, 95815, United States
Nature Coast Clinical Research - Crystal River /ID# 243519
Crystal River, Florida, 34429, United States
Segal Drug Trials, Inc /ID# 243521
Delray Beach, Florida, 33484, United States
Eye Associates of Fort Meyers /ID# 243545
Fort Myers, Florida, 33901, United States
Levenson Eye Associates Inc. /ID# 243532
Jacksonville, Florida, 32204, United States
Emory University /ID# 243534
Atlanta, Georgia, 30322-1013, United States
Clayton Eye Clinical Research, LLC /ID# 243530
Morrow, Georgia, 30260-4180, United States
Coastal Research Associates /ID# 243525
Roswell, Georgia, 30076, United States
Kannarr Eye Care /ID# 243542
Pittsburg, Kansas, 66762-2620, United States
Cincinnati Eye Institute- Edgewood /ID# 243810
Edgewood, Kentucky, 41017-3415, United States
The Eye Care Institute /ID# 243588
Louisville, Kentucky, 40206-1738, United States
Fraser Eye Center /ID# 244038
Fraser, Michigan, 48026, United States
Silverstein Eye Centers /ID# 243546
Kansas City, Missouri, 64034, United States
Eye Associates of North Jersey /ID# 243913
Dover, New Jersey, 07801-1629, United States
Northern New Jersey Eye Institute PA /ID# 243522
South Orange, New Jersey, 07079-1855, United States
Rochester Ophthalmological Group PC /ID# 243539
Rochester, New York, 14618-2616, United States
EyeCare Professionals Inc /ID# 243938
Powell, Ohio, 43065, United States
Scott and Christie and Associates /ID# 243548
Cranberry Township, Pennsylvania, 16066, United States
University Eye Surgeons /ID# 243926
Maryville, Tennessee, 37805, United States
Advancing Vision Research /ID# 243529
Smyrna, Tennessee, 37167, United States
Key-Whitman Eye Center /ID# 243928
Dallas, Texas, 75243, United States
Eye associates /ID# 243526
San Antonio, Texas, 78229, United States
Parkhurst Nuvision /ID# 244041
San Antonio, Texas, 78229, United States
Hoopes, Durrie, Rivera Research /ID# 243535
Draper, Utah, 84020-7133, United States
Country Hills Eye Center /ID# 243520
Ogden, Utah, 84403-2200, United States
Southern Utah Medical Research /ID# 243931
St. George, Utah, 84790, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ALLERGAN INC.
Allergan
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2022
First Posted
May 26, 2022
Study Start
June 9, 2022
Primary Completion
April 4, 2023
Study Completion
April 4, 2023
Last Updated
June 29, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- 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/
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.