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

Withdrawn before enrolling · Phase 2

Conditions studied: Presbyopia

In brief

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.

Key facts

Study ID

NCT05393089

Run by

Allergan

People needed

0

Starts

2022-06-09

Expected to finish

2023-04-04

Last updated by the study team

2022-06-29

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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).

Where it is running

• 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

Full record on ClinicalTrials.gov

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