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Phase 3 Efficacy Study of AGN-190584 in Participants With Presbyopia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03804268
Recruitment Status : Completed
First Posted : January 15, 2019
Last Update Posted : November 2, 2020
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Description
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Brief Summary:
A study to evaluate the efficacy, safety, and pharmacokinetics of AGN-190584 when administered bilaterally, once daily for 30 days in participants with presbyopia.

Condition or disease Intervention/treatment Phase
Presbyopia Drug: AGN-190584 Drug: Vehicle Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 323 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 3, Multicenter, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety and Efficacy of AGN-190584 in Participants With Presbyopia
Actual Study Start Date : December 21, 2018
Actual Primary Completion Date : October 31, 2019
Actual Study Completion Date : October 31, 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: AGN-190584
One drop bilaterally, once daily for 30 days
 Drug: AGN-190584
One drop bilaterally, once daily for 30 days
Placebo Comparator: Vehicle
One drop bilaterally, once daily for 30 days
 Drug: Vehicle
One drop bilaterally, once daily for 30 days


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of participants gaining 3 lines or more in mesopic, high contrast, binocular DCNVA (distance-corrected near visual acuity) [ Time Frame: Day 30 ]
    Visual acuity will be measured in mesopic conditions.


Secondary Outcome Measures :
  1. Proportion of participants gaining 3 lines or more in mesopic, high contrast, binocular DCNVA [ Time Frame: Day 30 ]
    Visual acuity will be measured in mesopic conditions.


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03804268


Locations
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Sponsors and Collaborators
Allergan
Investigators
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Study Director: Eleonora Safyan Allergan
More Information
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Additional Information:

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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03804268    
Other Study ID Numbers: 1883-301-013
First Posted: January 15, 2019    Key Record Dates
Last Update Posted: November 2, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Presbyopia
Refractive Errors
Eye Diseases