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

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ClinicalTrials.gov Identifier: NCT02595528
Recruitment Status : Completed
First Posted : November 3, 2015
Last Update Posted : October 18, 2018
Sponsor:
Information provided by (Responsible Party):
Allergan

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).

Condition or disease Intervention/treatment Phase
Presbyopia Drug: AGN-199201 ophthalmic solution Drug: AGN-190584 ophthalmic solution Drug: AGN-190584 vehicle Drug: AGN-199201 + AGN-190584 Combination Drug: AGN-199201 vehicle Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 163 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : April 29, 2016
Actual Primary Completion Date : October 18, 2017
Actual Study Completion Date : October 18, 2017

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




Primary Outcome Measures :
  1. Weighted Average Change from Baseline in Uncorrected Near Visual Acuity (UNVA) Letters [ Time Frame: Baseline, Between hour 1 and hour 10 of each of the five 2-day dosing periods ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT02595528


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

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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02595528     History of Changes
Other Study ID Numbers: 199201-009
First Posted: November 3, 2015    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018

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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
Ophthalmic Solutions
Pharmaceutical Solutions