Clinical trial NCT02780115: A Safety, Efficacy and Pharmacokinetic Study of AGN-199201 and AGN-190584 in Patients With Presbyopia
Official title: A Phase 2, Multicenter, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety, Efficacy, and Pharmacokinetics of the Fixed Combination of AGN-199201 and AGN-190584 in Patients With Presbyopia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Presbyopia
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2016-05-23
Enrollment: 151
Sex: ALL
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a safety, efficacy and pharmacokinetics study of the fixed combination of AGN-199201 and AGN-190584 in participants with presbyopia (inability to focus on items close-up).


Eligibility 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.

Primary outcomes:
measure: Weighted Average Change From Baseline in Uncorrected Near Visual Acuity (UNVA) Letters in the Nondominant Eye
timeFrame: Baseline, Day 28
Secondary outcomes:
measure: Number of Participants Experiencing One or More Treatment Emergent Adverse Events (TEAEs)
timeFrame: up to 65 days
Other outcomes:
Locations:
city: Arcadia
country: United States
facility: Retina Institute of California Medical Group
state: California
city: Artesia
country: United States
facility: Sall Research Medical Center
state: California
city: Cypress
country: United States
facility: WCCT Global, LLC
state: California
city: Glendale
country: United States
facility: Specialty Eye Care Medical Center
state: California
city: Glendale
country: United States
facility: Lugene Eye Institute
state: California
city: Newport Beach
country: United States
facility: The Eye Research Foundation
state: California
city: Palo Alto
country: United States
facility: Stanford Eye and Laser Center
state: California
city: Torrance
country: United States
facility: Wolstan and Golberg Eye Associates
state: California
city: Miami
country: United States
facility: MedEye Associates
state: Florida
city: Ocala
country: United States
facility: Central Florida Eye Institute
state: Florida
city: Sarasota
country: United States
facility: Center for Sight
state: Florida
city: Morrow
country: United States
facility: Clayton Eye Center
state: Georgia
city: Louisville
country: United States
facility: Silverstein Eye Centers
state: Kentucky
city: Louisville
country: United States
facility: The Eye Care Institute
state: Kentucky
city: Baltimore
country: United States
facility: Specialized Eye Care
state: Maryland
city: Winston-Salem
country: United States
facility: James D. Branch
state: North Carolina
city: Portland
country: United States
facility: Devers Eye Institute
state: Oregon
city: Cranberry Township
country: United States
facility: Scott & Christie and Associates, PC
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Memphis
country: United States
facility: Total Eye Care, PA
state: Tennessee
city: El Paso
country: United States
facility: Cataract and Glaucoma Center
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: San Antonio
country: United States
facility: R and R Eye Research, LLC
state: Texas
city: San Antonio
country: United States
facility: Medical Center Ophthalmology Associates
state: Texas
city: Draper
country: United States
facility: Hoopes Durrie Rivera Research, LLC
state: Utah
Study officials:
affiliation: Allergan
name: Haixia Liu
role: STUDY_DIRECTOR
References:
citation: Shirneshan E, Coon CD, Johnson N, Stokes J, Wells T, Lundy JJ, Andrae DA, Evans CJ, Campbell J. Development of the Near Vision Presbyopia Task-based Questionnaire for use in evaluating the impact of presbyopia. J Patient Rep Outcomes. 2021 Dec 2;5(1):125. doi: 10.1186/s41687-021-00378-y.
citation: Johnson N, Shirneshan E, Coon CD, Stokes J, Wells T, Lundy JJ, Andrae DA, Evans CJ, Campbell J. Development of the Presbyopia Impact and Coping Questionnaire. Ophthalmol Ther. 2021 Dec;10(4):1057-1075. doi: 10.1007/s40123-021-00391-w. Epub 2021 Oct 13.