A Safety, Efficacy and Pharmacokinetic Study of AGN-199201 and AGN-190584 in Patients With Presbyopia

December 1, 2020 updated by: Allergan

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

151

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Arcadia, California, United States, 91007
        • Retina Institute of California Medical Group
      • Artesia, California, United States, 90701
        • Sall Research Medical Center
      • Cypress, California, United States, 90630
        • WCCT Global, LLC
      • Glendale, California, United States, 91204
        • Lugene Eye Institute
      • Glendale, California, United States, 91203
        • Specialty Eye Care Medical Center
      • Newport Beach, California, United States, 92663
        • The Eye Research Foundation
      • Palo Alto, California, United States, 94303
        • Stanford Eye and Laser Center
      • Torrance, California, United States, 90505
        • Wolstan and Golberg Eye Associates
    • Florida
      • Miami, Florida, United States, 33143
        • MedEye Associates
      • Ocala, Florida, United States, 34474
        • Central Florida Eye Institute
      • Sarasota, Florida, United States, 34239
        • Center for Sight
    • Georgia
      • Morrow, Georgia, United States, 30260
        • Clayton Eye Center
    • Kentucky
      • Louisville, Kentucky, United States, 40206
        • The Eye Care Institute
      • Louisville, Kentucky, United States, 40206
        • Silverstein Eye Centers
    • Maryland
      • Baltimore, Maryland, United States, 21210
        • Specialized Eye Care
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27101
        • James D. Branch
    • Oregon
      • Portland, Oregon, United States, 97210
        • Devers Eye Institute
    • Pennsylvania
      • Cranberry Township, Pennsylvania, United States, 16066
        • Scott & Christie and Associates, PC
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Total Eye Care, PA
    • Texas
      • El Paso, Texas, United States, 79902
        • Cataract and Glaucoma Center
      • Galveston, Texas, United States, 77555
        • University of Texas Medical Branch
      • San Antonio, Texas, United States, 78240
        • Medical Center Ophthalmology Associates
      • San Antonio, Texas, United States, 78229
        • R and R Eye Research, LLC
    • Utah
      • Draper, Utah, United States, 84020
        • Hoopes Durrie Rivera Research, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 55 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1: Vehicle Control
Vehicle dosed in both eyes administered once daily during office visits 1 through 5.
Drug: AGN-199201 Vehicle
Vehicle to AGN-199201
Drug: AGN-190584 Vehicle
Vehicle to AGN-190584
Experimental: Cohort 2: AGN-199201 Dose A and AGN-190584 Dose A
Fixed combinations of AGN-199201 Dose A and AGN-190584 Dose A dosed in both eyes administered once daily during office visits 1 through 5.
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 of AGN-190584 ophthalmic solution Doses A, B, C in the eye.
Experimental: Cohort 3: AGN-199201 Dose B and AGN-190584 Dose B
Fixed combinations of AGN-199201 Dose B and AGN-190584 Dose B dosed in both eyes administered once daily during office visits 1 through 5.
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 of AGN-190584 ophthalmic solution Doses A, B, C in the eye.
Experimental: Cohort 4: AGN-199201 Dose C and AGN-190584 Dose C
Fixed combinations of AGN-199201 Dose C and AGN-190584 Dose C dosed in both eyes administered once daily during office visits 1 through 5.
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 of AGN-190584 ophthalmic solution Doses A, B, C in the eye.
Experimental: Cohort 5: Vehicle, AGN-199201 Dose C and AGN-190584 Dose C
Dominant eye dosed with Vehicle. Fixed combinations of AGN-199201 Dose C and AGN-190584 Dose C dosed in nondominant eye. Treatment administered once daily during office visits 1 through 5.
Drug: AGN-199201 Vehicle
Vehicle to AGN-199201
Drug: AGN-190584 Vehicle
Vehicle to AGN-190584
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 of AGN-190584 ophthalmic solution Doses A, B, C in the eye.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weighted Average Change From Baseline in Uncorrected Near Visual Acuity (UNVA) Letters in the Nondominant Eye
Time Frame: Baseline, Day 28
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, Day 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Experiencing One or More Treatment Emergent Adverse Events (TEAEs)
Time Frame: up to 65 days
A Treatment Emergent Adverse Event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. An Adverse Drug Reaction was a harmful and unintended reaction that is incurred during routine administration or use of the drug, whose causal relationship with the drug cannot be excluded.
up to 65 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Investigators

  • Study Director: Haixia Liu, Allergan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 26, 2016

Primary Completion (Actual)

October 31, 2017

Study Completion (Actual)

October 31, 2017

Study Registration Dates

First Submitted

May 19, 2016

First Submitted That Met QC Criteria

May 19, 2016

First Posted (Estimate)

May 23, 2016

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

Other Study ID Numbers

  • 199201-010

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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