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

Primary Purpose

Presbyopia

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AGN-190584
Vehicle
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Presbyopia focused on measuring Presbyopia, Pseudophakic Presbyopia, AGN-190584, ARIES, Pilocarpine HCl

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Trinity Research Group /ID# 243541
  • Arizona Eye Center /ID# 243897
  • Global Research Management /ID# 243544
  • United Medical Research Institute /ID# 243531
  • Salvay Vision /ID# 243828
  • The Eye Research Foundation /ID# 243524
  • Sacramento Eye Consultants /ID# 243538
  • Nature Coast Clinical Research - Crystal River /ID# 243519
  • Segal Drug Trials, Inc /ID# 243521
  • Eye Associates of Fort Meyers /ID# 243545
  • Levenson Eye Associates Inc. /ID# 243532
  • Emory University /ID# 243534
  • Clayton Eye Clinical Research, LLC /ID# 243530
  • Coastal Research Associates /ID# 243525
  • Kannarr Eye Care /ID# 243542
  • Cincinnati Eye Institute- Edgewood /ID# 243810
  • The Eye Care Institute /ID# 243588
  • Fraser Eye Center /ID# 244038
  • Silverstein Eye Centers /ID# 243546
  • Eye Associates of North Jersey /ID# 243913
  • Northern New Jersey Eye Institute PA /ID# 243522
  • Rochester Ophthalmological Group PC /ID# 243539
  • EyeCare Professionals Inc /ID# 243938
  • Scott and Christie and Associates /ID# 243548
  • University Eye Surgeons /ID# 243926
  • Advancing Vision Research /ID# 243529
  • Key-Whitman Eye Center /ID# 243928
  • Eye associates /ID# 243526
  • Parkhurst Nuvision /ID# 244041
  • Hoopes, Durrie, Rivera Research /ID# 243535
  • Country Hills Eye Center /ID# 243520
  • Southern Utah Medical Research /ID# 243931

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AGN-190584

Vehicle

Arm Description

Participants will receive one drop of AGN-190584 instilled in each eye once daily for 14 days.

Participants will receive one drop of vehicle instilled in each eye once daily for 14 days.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 23, 2022
Last Updated
June 24, 2022
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT05393089
Brief Title
Study of AGN-190584 Eye Drops to Assess Safety and Efficacy in Participants Aged 40-80 Years With Pseudophakic Presbyopia
Acronym
ARIES
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Business Decision
Study Start Date
June 9, 2022 (Anticipated)
Primary Completion Date
April 4, 2023 (Anticipated)
Study Completion Date
April 4, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbyopia
Keywords
Presbyopia, Pseudophakic Presbyopia, AGN-190584, ARIES, Pilocarpine HCl

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AGN-190584
Arm Type
Experimental
Arm Description
Participants will receive one drop of AGN-190584 instilled in each eye once daily for 14 days.
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Participants will receive one drop of vehicle instilled in each eye once daily for 14 days.
Intervention Type
Drug
Intervention Name(s)
AGN-190584
Intervention Description
Eye drops
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
Eye drops
Primary Outcome Measure Information:
Title
Number of Participants Experiencing Adverse Events (AEs)
Description
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.
Time Frame
Up to approximately 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ALLERGAN INC.
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Trinity Research Group /ID# 243541
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36301
Country
United States
Facility Name
Arizona Eye Center /ID# 243897
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Global Research Management /ID# 243544
City
Glendale
State/Province
California
ZIP/Postal Code
91204-2500
Country
United States
Facility Name
United Medical Research Institute /ID# 243531
City
Inglewood
State/Province
California
ZIP/Postal Code
90301
Country
United States
Facility Name
Salvay Vision /ID# 243828
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663-3600
Country
United States
Facility Name
The Eye Research Foundation /ID# 243524
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663-3637
Country
United States
Facility Name
Sacramento Eye Consultants /ID# 243538
City
Sacramento
State/Province
California
ZIP/Postal Code
95815
Country
United States
Facility Name
Nature Coast Clinical Research - Crystal River /ID# 243519
City
Crystal River
State/Province
Florida
ZIP/Postal Code
34429
Country
United States
Facility Name
Segal Drug Trials, Inc /ID# 243521
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484
Country
United States
Facility Name
Eye Associates of Fort Meyers /ID# 243545
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Levenson Eye Associates Inc. /ID# 243532
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Emory University /ID# 243534
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322-1013
Country
United States
Facility Name
Clayton Eye Clinical Research, LLC /ID# 243530
City
Morrow
State/Province
Georgia
ZIP/Postal Code
30260-4180
Country
United States
Facility Name
Coastal Research Associates /ID# 243525
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Kannarr Eye Care /ID# 243542
City
Pittsburg
State/Province
Kansas
ZIP/Postal Code
66762-2620
Country
United States
Facility Name
Cincinnati Eye Institute- Edgewood /ID# 243810
City
Edgewood
State/Province
Kentucky
ZIP/Postal Code
41017-3415
Country
United States
Facility Name
The Eye Care Institute /ID# 243588
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40206-1738
Country
United States
Facility Name
Fraser Eye Center /ID# 244038
City
Fraser
State/Province
Michigan
ZIP/Postal Code
48026
Country
United States
Facility Name
Silverstein Eye Centers /ID# 243546
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64034
Country
United States
Facility Name
Eye Associates of North Jersey /ID# 243913
City
Dover
State/Province
New Jersey
ZIP/Postal Code
07801-1629
Country
United States
Facility Name
Northern New Jersey Eye Institute PA /ID# 243522
City
South Orange
State/Province
New Jersey
ZIP/Postal Code
07079-1855
Country
United States
Facility Name
Rochester Ophthalmological Group PC /ID# 243539
City
Rochester
State/Province
New York
ZIP/Postal Code
14618-2616
Country
United States
Facility Name
EyeCare Professionals Inc /ID# 243938
City
Powell
State/Province
Ohio
ZIP/Postal Code
43065
Country
United States
Facility Name
Scott and Christie and Associates /ID# 243548
City
Cranberry Township
State/Province
Pennsylvania
ZIP/Postal Code
16066
Country
United States
Facility Name
University Eye Surgeons /ID# 243926
City
Maryville
State/Province
Tennessee
ZIP/Postal Code
37805
Country
United States
Facility Name
Advancing Vision Research /ID# 243529
City
Smyrna
State/Province
Tennessee
ZIP/Postal Code
37167
Country
United States
Facility Name
Key-Whitman Eye Center /ID# 243928
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243
Country
United States
Facility Name
Eye associates /ID# 243526
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Parkhurst Nuvision /ID# 244041
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Hoopes, Durrie, Rivera Research /ID# 243535
City
Draper
State/Province
Utah
ZIP/Postal Code
84020-7133
Country
United States
Facility Name
Country Hills Eye Center /ID# 243520
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403-2200
Country
United States
Facility Name
Southern Utah Medical Research /ID# 243931
City
Saint George
State/Province
Utah
ZIP/Postal Code
84790
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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 Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing 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/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/

Learn more about this trial

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

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