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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Eye drops
Eye drops
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
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.
Time frame: Up to approximately 14 days
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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
...and 22 more locations