A Study of the Concurrent Use of AGN-190584 and AGN-199201 in Participants With Presbyopia

A Phase 2, Multicenter, Double-masked, Randomized, Vehicle-Controlled, Study of the Concurrent Use of AGN-190584 and AGN-199201 in Patients With Presbyopia

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).

Study Overview

• Status: Completed
• Conditions: Presbyopia
• Intervention / Treatment: Drug: AGN-199201 ophthalmic solution; Drug: AGN-190584 ophthalmic solution; Drug: AGN-190584 vehicle; Drug: AGN-199201 + AGN-190584 Combination; Drug: AGN-199201 vehicle

• Study Type: Interventional
• Enrollment (Actual): 163
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Artesia, California, United States, 90701
      • Sall Research Medical Center
    • Azusa, California, United States, 91702
      • Milton M. Hom, OD, FAAO
    • Costa Mesa, California, United States, 92626
      • WCCT Global, LLC
    • Newport Beach, California, United States, 92663
      • The Eye Research Foundation
    • Petaluma, California, United States, 94954
      • North Bay Eye Associates, Inc.
    • Rancho Cordova, California, United States, 95670
      • Martel Eye Medical Group
    • San Diego, California, United States, 92115
      • West Coast Eye Care
  • Colorado
    • Littleton, Colorado, United States, 80120
      • Corneal Consultants of Colorado, P.C.
  • Florida
    • Mount Dora, Florida, United States, 32757
      • Mid Florida Eye Center
  • Georgia
    • Morrow, Georgia, United States, 30260
      • Clayton Eye Center
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Price Vision Group
  • Maryland
    • Baltimore, Maryland, United States, 21210
      • Specialized Eye Care
  • Missouri
    • Washington, Missouri, United States, 63090
      • Comprehensive Eye Care, Ltd
  • Ohio
    • Brecksville, Ohio, United States, 44141
      • Cleveland Eye Clinic
  • Pennsylvania
    • Cranberry Township, Pennsylvania, United States, 16066
      • Scott & Christie and Associates, PC
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Total Eye Care, PA
  • Texas
    • El Paso, Texas, United States, 79902
      • Cataract and Glaucoma Center
    • San Antonio, Texas, United States, 78240
      • Medical Center Ophthalmology Associates
  • Utah
    • Draper, Utah, United States, 84020
      • Hoopes Durrie Rivera Research, LLC
  • Wisconsin
    • Kenosha, Wisconsin, United States, 53142
      • The Eye Centers of Racine & Kenosha

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AGN-199201 and AGN-190584 Vehicle; Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Dose A followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Dose B followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Dose C followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle.	Drug: AGN-199201 ophthalmic solution; 1 drop of AGN-199201 ophthalmic solution Doses A, B, C in the eye.; Drug: AGN-190584 ophthalmic solution; 1 drop AGN-190584 ophthalmic solution doses A, B and C in the eye.; Drug: AGN-190584 vehicle; Vehicle to AGN-190584; Drug: AGN-199201 + AGN-190584 Combination; 1 drop AGN-199201 and AGN-190584 fixed combination ophthalmic solution in the eye.; Drug: AGN-199201 vehicle; Vehicle to AGN-199201
Experimental: AGN-199201 and AGN-190584 Dose A; Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Dose A, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Dose A followed by 1 drop AGN-190584 Dose A, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Dose B followed by 1 drop AGN-190584 Dose A, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Dose C followed by 1 drop AGN-190584 Dose A, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle.	Drug: AGN-199201 ophthalmic solution; 1 drop of AGN-199201 ophthalmic solution Doses A, B, C in the eye.; Drug: AGN-190584 ophthalmic solution; 1 drop AGN-190584 ophthalmic solution doses A, B and C in the eye.; Drug: AGN-190584 vehicle; Vehicle to AGN-190584; Drug: AGN-199201 + AGN-190584 Combination; 1 drop AGN-199201 and AGN-190584 fixed combination ophthalmic solution in the eye.; Drug: AGN-199201 vehicle; Vehicle to AGN-199201
Experimental: AGN-199201 and AGN-190584 Dose B; Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Dose B, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Dose A followed by 1 drop AGN-190584 Dose B, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Dose B followed by 1 drop AGN-190584 Dose B, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Dose C followed by 1 drop AGN-190584 Dose B, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle.	Drug: AGN-199201 ophthalmic solution; 1 drop of AGN-199201 ophthalmic solution Doses A, B, C in the eye.; Drug: AGN-190584 ophthalmic solution; 1 drop AGN-190584 ophthalmic solution doses A, B and C in the eye.; Drug: AGN-190584 vehicle; Vehicle to AGN-190584; Drug: AGN-199201 + AGN-190584 Combination; 1 drop AGN-199201 and AGN-190584 fixed combination ophthalmic solution in the eye.; Drug: AGN-199201 vehicle; Vehicle to AGN-199201
Experimental: AGN-199201 and AGN-190584 Dose C; Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Dose C, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Dose A followed by 1 drop AGN-190584 Dose C, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Dose B followed by 1 drop AGN-190584 Dose C, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Dose C followed by 1 drop AGN-190584 Dose C, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle.	Drug: AGN-199201 ophthalmic solution; 1 drop of AGN-199201 ophthalmic solution Doses A, B, C in the eye.; Drug: AGN-190584 ophthalmic solution; 1 drop AGN-190584 ophthalmic solution doses A, B and C in the eye.; Drug: AGN-190584 vehicle; Vehicle to AGN-190584; Drug: AGN-199201 + AGN-190584 Combination; 1 drop AGN-199201 and AGN-190584 fixed combination ophthalmic solution in the eye.; Drug: AGN-199201 vehicle; Vehicle to AGN-199201

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weighted Average Change From Baseline in Mesopic, High Contrast Uncorrected Near Visual Acuity (UNVA) Letters	UNVA is assessed without corrective lenses in the non-dominant eye. UNVA is measured using an eye chart and is reported as the number of lines read correctly. The lower the number of lines read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of lines read correctly means that vision has improved.	Baseline, Between hour 1 and hour 10 of each of the five 2-day dosing periods

Collaborators and Investigators

• Sponsor: Allergan
• Investigators: Study Director: Haixia Liu, Allergan

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2016
• Primary Completion (Actual): October 18, 2017
• Study Completion (Actual): October 18, 2017

Study Registration Dates

• First Submitted: November 2, 2015
• First Submitted That Met QC Criteria: November 2, 2015
• First Posted (Estimate): November 3, 2015

Study Record Updates

• Last Update Posted (Actual): December 22, 2020
• Last Update Submitted That Met QC Criteria: December 1, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia; Ophthalmic Solutions; Pharmaceutical Solutions
• Other Study ID Numbers: 199201-009

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No