A Phase 3 Efficacy Study of Pilocarpine HCl Ophthalmic Solution (AGN-190584) in Participants With Presbyopia
NCT ID: NCT03857542
Last Updated: 2021-12-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
427 participants
INTERVENTIONAL
2019-03-01
2020-09-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Vehicle
Participants received one drop of vehicle in each eye, once daily, for up to 30 days.
Vehicle
Vehicle, one drop in each eye, once daily, for up to 30 days.
Pilocarpine HCl Ophthalmic Solution
Participants received one drop of pilocarpine HCl ophthalmic solution 1.25% in each eye, once daily, for up to 30 days.
Pilocarpine HCl Ophthalmic Solution
Pilocarpine HCl ophthalmic solution 1.25%, one drop in each eye, once daily, for up to 30 days.
Interventions
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Pilocarpine HCl Ophthalmic Solution
Pilocarpine HCl ophthalmic solution 1.25%, one drop in each eye, once daily, for up to 30 days.
Vehicle
Vehicle, one drop in each eye, once daily, for up to 30 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Known allergy or sensitivity to the study intervention or its components or other cholinergic agonist medications
Concurrent use of any topical ophthalmic medications, including artificial tears, other than the study intervention during the course of the study
Concurrent use of temporary or permanent punctal plugs or history of punctal cautery in one or both eyes
Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study
Participation in a blood or plasma donation program within 30 days prior to study intervention administration
Severe dry eye disease (defined as total corneal staining ≥ grade 3 on the 5-point Oxford scale and an ocular surface disease index (OSDI) score of \> 33) at the screening visit
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
History of iris trauma, Adie's tonic pupil, abnormal pupil shape in either eye, or anisocoria \> 1 mm between pupils under mesopic conditions at the screening visit
Lens opacity in either eye that is determined to cause significant disturbance of the central visual axis on screening biomicroscopy
Diagnosis of any type of glaucoma or ocular hypertension
Bifocal or multifocal spectacles or contact lenses for habitual correction. Participants willing to wear study-provided monofocal correction (either spectacles or contact lenses) during the study can be enrolled
Abnormal and clinically significant results according to the investigator or designee, on physical/ophthalmic examination or medical history
Females who are pregnant, nursing, or planning a pregnancy during the study
Exclusion Criteria
40 Years
55 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Eleonora Safyan
Role: STUDY_DIRECTOR
Allergan
Locations
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Eye Center South
Dothan, Alabama, United States
M&M Eye Institute
Prescott, Arizona, United States
Walman Eye Center
Sun City, Arizona, United States
Milton M. Hom, OD, FAAO
Azusa, California, United States
Global Research Management
Glendale, California, United States
Advanced Vision Care
Los Angeles, California, United States
North Valley Eye Medical Group, Inc.
Mission Hills, California, United States
Eye Research Foundation
Newport Beach, California, United States
Corneal Consultants of Colorado
Littleton, Colorado, United States
Benjamin Knox Lambright, MD
Crystal River, Florida, United States
South Florida Vision Center
Fort Lauderdale, Florida, United States
Bowden Eye Associates
Jacksonville, Florida, United States
Mid Florida Eye Center
Mt. Dora, Florida, United States
Newsom Eye & Laser Center
Sebring, Florida, United States
Clayton Eye Center
Morrow, Georgia, United States
The Midwest Center for Sight
Des Plaines, Illinois, United States
Jacksoneye
Lake Villa, Illinois, United States
Kannarr Eye Care
Pittsburg, Kansas, United States
Heart of America Eyecare
Shawnee Mission, Kansas, United States
Cincinnati Eye Institute
Edgewood, Kentucky, United States
Chu Laser Eye Institute
Bloomington, Minnesota, United States
Silverstein Eye Centers
Kansas City, Missouri, United States
Moyes Eye Center
Kansas City, Missouri, United States
Tekwani Vision Center
St Louis, Missouri, United States
Amel Youssef, OD
Las Vegas, Nevada, United States
Debry Medical Services PC
Las Vegas, Nevada, United States
Bucci Laser Vision
Wilkes-Barre, Pennsylvania, United States
Waring Vision Institute
Mt. Pleasant, South Carolina, United States
University Eye Surgeons
Maryville, Tennessee, United States
Total Eye Care, PA
Memphis, Tennessee, United States
Keystone Research ltd. at Texan Eye
Austin, Texas, United States
The Cataract and Glaucoma Center
El Paso, Texas, United States
Texas Eye & Laser Ctr
Hurst, Texas, United States
Benjamin Travis Dastrup, MD
Ogden, Utah, United States
Vision Consultants and Surgeons
Falls Church, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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1883-302-013
Identifier Type: -
Identifier Source: org_study_id