Status:
WITHDRAWN
Study of AGN-190584 Eye Drops to Assess Safety and Efficacy in Participants Aged 40-80 Years With Pseudophakic Presbyopia
Lead Sponsor:
Allergan
Conditions:
Presbyopia
Eligibility:
All Genders
40-80 years
Phase:
PHASE2
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 tr...
Eligibility Criteria
Inclusion
- 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
- \- 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).
Key Trial Info
Start Date :
June 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 4 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05393089
Start Date
June 9 2022
End Date
April 4 2023
Last Update
June 29 2022
Active Locations (32)
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1
Trinity Research Group /ID# 243541
Dothan, Alabama, United States, 36301
2
Arizona Eye Center /ID# 243897
Chandler, Arizona, United States, 85224
3
Global Research Management /ID# 243544
Glendale, California, United States, 91204-2500
4
United Medical Research Institute /ID# 243531
Inglewood, California, United States, 90301