A Study of the Concurrent Use of AGN-190584 and AGN-199201 in Participants With Presbyopia

Study Identifier
199201-009
CT.gov Identifier
NCT02595528
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-190584 vehicle
  • AGN-199201 + AGN-190584 Combination
  • AGN-199201 vehicle
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    40 - 50 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 study will identify the optimum concentrations of AGN-199201 and AGN-190584 when dosed in combination once a day for the improvement of uncorrected near visual acuity in participants with presbyopia (inability to focus on items close-up).

    Study Locations

    Location
    Status
    Location
    Sall Research Medical Center
    Artesia, California, United States, 90701
    Status
    Not applicable
    Location
    Milton M. Hom, OD, FAAO
    Azusa, California, United States, 91702
    Status
    Not applicable
    Location
    WCCT Global, LLC
    Costa Mesa, California, United States, 92626
    Status
    Not applicable
    Location
    The Eye Research Foundation
    Newport Beach, California, United States, 92663
    Status
    Not applicable
    Location
    North Bay Eye Associates, Inc.
    Petaluma, California, United States, 94954
    Status
    Not applicable
    Location
    Martel Eye Medical Group
    Rancho Cordova, California, United States, 95670
    Status
    Not applicable
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