Clinical trial NCT02595528: A Study of the Concurrent Use of AGN-190584 and AGN-199201 in Participants With Presbyopia
Official title: A Phase 2, Multicenter, Double-masked, Randomized, Vehicle-Controlled, Study of the Concurrent Use of AGN-190584 and AGN-199201 in Patients With Presbyopia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Presbyopia
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2015-11-03
Enrollment: 163
Sex: ALL
Minimum age (years): 40
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will identify the optimum concentrations of AGN-199201 and AGN-190584 when dosed in combination once a day for the improvement of uncorrected near visual acuity 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 Mesopic, High Contrast Uncorrected Near Visual Acuity (UNVA) Letters
timeFrame: Baseline, Between hour 1 and hour 10 of each of the five 2-day dosing periods
Secondary outcomes:
Other outcomes:
Locations:
city: Artesia
country: United States
facility: Sall Research Medical Center
state: California
city: Azusa
country: United States
facility: Milton M. Hom, OD, FAAO
state: California
city: Costa Mesa
country: United States
facility: WCCT Global, LLC
state: California
city: Newport Beach
country: United States
facility: The Eye Research Foundation
state: California
city: Petaluma
country: United States
facility: North Bay Eye Associates, Inc.
state: California
city: Rancho Cordova
country: United States
facility: Martel Eye Medical Group
state: California
city: San Diego
country: United States
facility: West Coast Eye Care
state: California
city: Littleton
country: United States
facility: Corneal Consultants of Colorado, P.C.
state: Colorado
city: Mount Dora
country: United States
facility: Mid Florida Eye Center
state: Florida
city: Morrow
country: United States
facility: Clayton Eye Center
state: Georgia
city: Indianapolis
country: United States
facility: Price Vision Group
state: Indiana
city: Baltimore
country: United States
facility: Specialized Eye Care
state: Maryland
city: Washington
country: United States
facility: Comprehensive Eye Care, Ltd
state: Missouri
city: Brecksville
country: United States
facility: Cleveland Eye Clinic
state: Ohio
city: Cranberry Township
country: United States
facility: Scott & Christie and Associates, PC
state: Pennsylvania
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: 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
city: Kenosha
country: United States
facility: The Eye Centers of Racine & Kenosha
state: Wisconsin
Study officials:
affiliation: Allergan
name: Haixia Liu
role: STUDY_DIRECTOR
References: