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

Study Identifier
M21-194
CT.gov Identifier
NCT05393089
EudraCT Identifier
Not available
EUCTIS ID
Not available
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Study Details

Medical Condition
  • Eye Care - Other
    • Study Drug
  • AGN-190584
  • Vehicle
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    40 - 80 Years
    Inclusion and Exclusion 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).

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    Trinity Research Group /ID# 243541
    Dothan, Alabama, United States, 36301
    Status
    Not applicable
    Location
    Arizona Eye Center /ID# 243897
    Chandler, Arizona, United States, 85224
    Status
    Not applicable
    Location
    Global Research Management /ID# 243544
    Glendale, California, United States, 91204-2500
    Status
    Not applicable
    Location
    United Medical Research Institute /ID# 243531
    Inglewood, California, United States, 90301
    Status
    Not applicable
    Location
    Salvay Vision /ID# 243828
    Newport Beach, California, United States, 92663-3600
    Status
    Not applicable
    Location
    The Eye Research Foundation /ID# 243524
    Newport Beach, California, United States, 92663-3637
    Status
    Not applicable
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