A Safety, Efficacy and Pharmacokinetic Study of AGN-199201 and AGN-190584 in Patients With Presbyopia

Study Identifier
199201-010
CT.gov Identifier
NCT02780115
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Statistical Analysis Plan
Available Language(s): English
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Protocol
Available Language(s): English
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Study Details

Medical Condition
  • Eye Care - Other
    • Study Drug
  • AGN-199201 ophthalmic solution
  • AGN-190584 ophthalmic solution
  • AGN-199201 Vehicle
  • AGN-190584 Vehicle
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    40 - 55 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Normal vision at distance, either natural or post corneal laser refractive surgery, with presbyopia in each eye and complaints of poor near vision that impacts activities of daily living
    Exclusion Criteria:
    * Use of any topical ophthalmic medications, including artificial tears other than the study medications during the study * Corneal abnormalities in either eye that interfere with visual acuity * History of cataract surgery, phakic intraocular lens surgery, corneal inlay surgery or any intraocular surgery * Diagnosis of glaucoma or ocular hypertension.

    Protocol Summary

    This is a safety, efficacy and pharmacokinetics study of the fixed combination of AGN-199201 and AGN-190584 in participants with presbyopia (inability to focus on items close-up).

    Study Locations

    Location
    Status
    Location
    Retina Institute of California Medical Group
    Arcadia, California, United States, 91007
    Status
    Not applicable
    Location
    Sall Research Medical Center
    Artesia, California, United States, 90701
    Status
    Not applicable
    Location
    WCCT Global, LLC
    Cypress, California, United States, 90630
    Status
    Not applicable
    Location
    Specialty Eye Care Medical Center
    Glendale, California, United States, 91203
    Status
    Not applicable
    Location
    Lugene Eye Institute
    Glendale, California, United States, 91204
    Status
    Not applicable
    Location
    The Eye Research Foundation
    Newport Beach, California, United States, 92663
    Status
    Not applicable
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