A Study to Assess Safety and Efficacy in Participants Age 40 to 55 With Presbyopia (Old Eye) Who Receive AGN-190584 in Both Eyes Twice Daily

Study Identifier
M21-195
CT.gov Identifier
NCT04983589
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
Download document(s)
Statistical Analysis Plan
Available Language(s): English
Download document(s)
Scientific Result Summary
Available Language(s): English
Download document(s)
Plain Language Summary
Available Language(s): English
Download document(s)

Study Details

Medical Condition
  • Eye Care - Other
    • Study Drug
  • Pilocarpine HCl
  • Vehicle
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    40 - 55 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    \- Objective and subjective evidence of presbyopia.
    Exclusion Criteria:
    * 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. * History of cataract surgery, phakic intraocular lens surgery, corneal inlay surgery, radial keratotomy, or any intraocular surgery. * Use of temporary or permanent punctal plugs or history of punctal cautery in one or both eyes.

    Protocol Summary

    Currently available treatments for presbyopia (old eye) include nonsurgical options (spectacles or contact lenses) and surgical options, however, each has its own risks and limitations. The purpose of this study is to evaluate how effective AGN-190584 is in treating presbyopia compared to vehicle (placebo).

    AGN-190584 is an investigational drug being developed for the treatment of presbyopia. Participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to vehicle. Around 200 participants age 40-55 years with a diagnosis of presbyopia will be enrolled in the study in approximately 20 sites in the United States.

    Participants will receive AGN-190584 or vehicle in each eye twice daily for 14 days.

    There may be additional procedures for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a doctor's office. The effect of the treatment will be checked by medical assessments, vision/eye tests, checking for side effects and completing questionnaires.

    Study Locations

    Location
    Status
    Location
    Empire Eye and Laser /ID# 231433
    Bakersfield, California, United States, 93309-0637
    Status
    Not applicable
    Location
    Global Research Management /ID# 231300
    Glendale, California, United States, 91204-2500
    Status
    Not applicable
    Location
    United Medical Research Institute /ID# 233982
    Inglewood, California, United States, 90301
    Status
    Not applicable
    Location
    North Valley Eye Medical Group, Inc. /ID# 231270
    Mission Hills, California, United States, 91345-1200
    Status
    Not applicable
    Location
    The Eye Research Foundation /ID# 231274
    Newport Beach, California, United States, 92663-3637
    Status
    Not applicable
    Location
    Martel Eye Medical Group /ID# 231332
    Rancho Cordova, California, United States, 95670-2968
    Status
    Not applicable
    Showing {first} - {last} of {total} Results