Efficacy Study of Pilocarpine HCl Ophthalmic Solution (AGN-190584) in Participants With Presbyopia

Study Identifier
1883-301-013
CT.gov Identifier
NCT03804268
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

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

Medical Condition
  • Eye Care - Other
    • Study Drug
  • Pilocarpine HCl Ophthalmic Solution
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    40 - 55 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    \- Subjective complaints of poor near vision that impact activities of daily living
    Exclusion Criteria:
    * History of cataract surgery, phakic intraocular lens surgery, corneal inlay surgery, radial keratotomy, or any intraocular surgery * Use of any topical ophthalmic medications, including artificial tears other than the study medications during the study * Use of temporary or permanent punctal plugs or history of punctal cautery in one or both eyes * Corneal abnormalities (including keratoconus, corneal scar, Fuchs' endothelial dystrophy, guttata, or edema) in either eye that are likely to interfere with visual acuity * Narrow iridocorneal angles (Shaffer grade ≤2 or lower on gonioscopy examination), history of angle-closure glaucoma, or previous iridotomy * Diagnosis of any type of glaucoma or ocular hypertension

    Protocol Summary

    A study to evaluate the efficacy, safety, and pharmacokinetics of pilocarpine hydrochloride (HCl) ophthalmic solution (AGN-190584) when administered bilaterally, once daily for 30 days in participants with presbyopia.

    Study Locations

    Location
    Status
    Location
    Arizona Eye Center
    Chandler, Arizona, United States, 85224
    Status
    Not applicable
    Location
    Schwartz Laser Eye Center
    Scottsdale, Arizona, United States, 85260
    Status
    Not applicable
    Location
    Assil Eye Institute
    Beverly Hills, California, United States, 90210
    Status
    Not applicable
    Location
    American Institute of Research
    Los Angeles, California, United States, 90017
    Status
    Not applicable
    Location
    Eye Research Foundation
    Newport Beach, California, United States, 92663
    Status
    Not applicable
    Location
    Martel Eye Medical Group
    Rancho Cordova, California, United States, 95670
    Status
    Not applicable
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