Phase 1/2 Study of AGN-241622 in Healthy Participants and Participants With Presbyopia

Study Identifier
2011-101-013
CT.gov Identifier
NCT04403763
EudraCT Identifier
Not available
EUCTIS ID
Not available
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844-663-3742 or [email protected]

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Protocol
Available Language(s): English
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Statistical Analysis Plan
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Scientific Result Summary
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Plain Language Summary
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Study Details

Medical Condition
  • Eye Care - Other
    • Study Drug
  • AGN-241622
  • Vehicle
    • Phase
    Phase 1/Phase 2
    Sex
    Female & Male
    Age
    40 - 65 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Age 40 to 65 at the time of study participation. * Be a nonsmoker and nonuser of nicotine-containing products within the previous 1 year. * Be able and willing to follow study instructions and complete all required study visits in the opinion of the study doctor.
    Exclusion Criteria:
    * History of alcohol or substance abuse within the 5 years prior to study participation. * Enrollment in another investigational drug or device study within 30 days of study participation. * Women who are pregnant, nursing, or planning a pregnancy during the study.

    Protocol Summary

    The objective of this study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of AGN-241622 ophthalmic solution for the first time in human participants

    Study Locations

    Location
    Status
    Location
    United Medical Research Institute /ID# 234612
    Inglewood, California, United States, 90301
    Status
    Not applicable
    Location
    Global Research Foundation /ID# 237353
    Los Angeles, California, United States, 90041-1718
    Status
    Not applicable
    Location
    North Valley Eye Medical Group, Inc. /ID# 236686
    Mission Hills, California, United States, 91345-1200
    Status
    Not applicable
    Location
    The Eye Research Foundation /ID# 234526
    Newport Beach, California, United States, 92663-3637
    Status
    Not applicable
    Location
    Quantum Clinical Trials /ID# 237330
    Miami Beach, Florida, United States, 33140
    Status
    Not applicable
    Location
    Kannarr Eye Care /ID# 236718
    Pittsburg, Kansas, United States, 66762-2620
    Status
    Not applicable
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