Study of AGN-190584 Eye Drops to Assess Safety and Efficacy in Participants Aged 40-80 Years With Pseudophakic Presbyopia
NCT ID: NCT05393089
Last Updated: 2022-06-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2022-06-09
2023-04-04
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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AGN-190584
Participants will receive one drop of AGN-190584 instilled in each eye once daily for 14 days.
AGN-190584
Eye drops
Vehicle
Participants will receive one drop of vehicle instilled in each eye once daily for 14 days.
Vehicle
Eye drops
Interventions
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AGN-190584
Eye drops
Vehicle
Eye drops
Eligibility Criteria
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Inclusion Criteria
* 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
40 Years
80 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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ALLERGAN INC.
Role: STUDY_DIRECTOR
Allergan
Locations
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Trinity Research Group /ID# 243541
Dothan, Alabama, United States
Arizona Eye Center /ID# 243897
Chandler, Arizona, United States
Global Research Management /ID# 243544
Glendale, California, United States
United Medical Research Institute /ID# 243531
Inglewood, California, United States
Salvay Vision /ID# 243828
Newport Beach, California, United States
The Eye Research Foundation /ID# 243524
Newport Beach, California, United States
Sacramento Eye Consultants /ID# 243538
Sacramento, California, United States
Nature Coast Clinical Research - Crystal River /ID# 243519
Crystal River, Florida, United States
Segal Drug Trials, Inc /ID# 243521
Delray Beach, Florida, United States
Eye Associates of Fort Meyers /ID# 243545
Fort Myers, Florida, United States
Levenson Eye Associates Inc. /ID# 243532
Jacksonville, Florida, United States
Emory University /ID# 243534
Atlanta, Georgia, United States
Clayton Eye Clinical Research, LLC /ID# 243530
Morrow, Georgia, United States
Coastal Research Associates /ID# 243525
Roswell, Georgia, United States
Kannarr Eye Care /ID# 243542
Pittsburg, Kansas, United States
Cincinnati Eye Institute- Edgewood /ID# 243810
Edgewood, Kentucky, United States
The Eye Care Institute /ID# 243588
Louisville, Kentucky, United States
Fraser Eye Center /ID# 244038
Fraser, Michigan, United States
Silverstein Eye Centers /ID# 243546
Kansas City, Missouri, United States
Eye Associates of North Jersey /ID# 243913
Dover, New Jersey, United States
Northern New Jersey Eye Institute PA /ID# 243522
South Orange, New Jersey, United States
Rochester Ophthalmological Group PC /ID# 243539
Rochester, New York, United States
EyeCare Professionals Inc /ID# 243938
Powell, Ohio, United States
Scott and Christie and Associates /ID# 243548
Cranberry Township, Pennsylvania, United States
University Eye Surgeons /ID# 243926
Maryville, Tennessee, United States
Advancing Vision Research /ID# 243529
Smyrna, Tennessee, United States
Key-Whitman Eye Center /ID# 243928
Dallas, Texas, United States
Eye associates /ID# 243526
San Antonio, Texas, United States
Parkhurst Nuvision /ID# 244041
San Antonio, Texas, United States
Hoopes, Durrie, Rivera Research /ID# 243535
Draper, Utah, United States
Country Hills Eye Center /ID# 243520
Ogden, Utah, United States
Southern Utah Medical Research /ID# 243931
St. George, Utah, United States
Countries
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Other Identifiers
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M21-194
Identifier Type: -
Identifier Source: org_study_id
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