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

Primary Purpose

Presbyopia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AGN-199201 ophthalmic solution
AGN-190584 ophthalmic solution
AGN-199201 Vehicle
AGN-190584 Vehicle
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Presbyopia

Eligibility Criteria

40 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Retina Institute of California Medical Group
  • Sall Research Medical Center
  • WCCT Global, LLC
  • Specialty Eye Care Medical Center
  • Lugene Eye Institute
  • The Eye Research Foundation
  • Stanford Eye and Laser Center
  • Wolstan and Golberg Eye Associates
  • MedEye Associates
  • Central Florida Eye Institute
  • Center for Sight
  • Clayton Eye Center
  • Silverstein Eye Centers
  • The Eye Care Institute
  • Specialized Eye Care
  • James D. Branch
  • Devers Eye Institute
  • Scott & Christie and Associates, PC
  • Medical University of South Carolina
  • Total Eye Care, PA
  • Cataract and Glaucoma Center
  • University of Texas Medical Branch
  • R and R Eye Research, LLC
  • Medical Center Ophthalmology Associates
  • Hoopes Durrie Rivera Research, LLC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort 1: Vehicle Control

Cohort 2: AGN-199201 Dose A and AGN-190584 Dose A

Cohort 3: AGN-199201 Dose B and AGN-190584 Dose B

Cohort 4: AGN-199201 Dose C and AGN-190584 Dose C

Cohort 5: Vehicle, AGN-199201 Dose C and AGN-190584 Dose C

Arm Description

Vehicle dosed in both eyes administered once daily during office visits 1 through 5.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Weighted Average Change From Baseline in Uncorrected Near Visual Acuity (UNVA) Letters in the Nondominant Eye
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.

Secondary Outcome Measures

Number of Participants Experiencing One or More Treatment Emergent Adverse Events (TEAEs)
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.

Full Information

First Posted
May 19, 2016
Last Updated
December 1, 2020
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT02780115
Brief Title
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

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
May 26, 2016 (Actual)
Primary Completion Date
October 31, 2017 (Actual)
Study Completion Date
October 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbyopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
151 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1: Vehicle Control
Arm Type
Experimental
Arm Description
Vehicle dosed in both eyes administered once daily during office visits 1 through 5.
Arm Title
Cohort 2: AGN-199201 Dose A and AGN-190584 Dose A
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort 3: AGN-199201 Dose B and AGN-190584 Dose B
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort 4: AGN-199201 Dose C and AGN-190584 Dose C
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort 5: Vehicle, AGN-199201 Dose C and AGN-190584 Dose C
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
AGN-199201 ophthalmic solution
Intervention Description
1 drop of AGN-199201 ophthalmic solution Doses A, B, C in the eye.
Intervention Type
Drug
Intervention Name(s)
AGN-190584 ophthalmic solution
Intervention Description
1 drop of AGN-190584 ophthalmic solution Doses A, B, C in the eye.
Intervention Type
Drug
Intervention Name(s)
AGN-199201 Vehicle
Intervention Description
Vehicle to AGN-199201
Intervention Type
Drug
Intervention Name(s)
AGN-190584 Vehicle
Intervention Description
Vehicle to AGN-190584
Primary Outcome Measure Information:
Title
Weighted Average Change From Baseline in Uncorrected Near Visual Acuity (UNVA) Letters in the Nondominant Eye
Description
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.
Time Frame
Baseline, Day 28
Secondary Outcome Measure Information:
Title
Number of Participants Experiencing One or More Treatment Emergent Adverse Events (TEAEs)
Description
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.
Time Frame
up to 65 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haixia Liu
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Retina Institute of California Medical Group
City
Arcadia
State/Province
California
ZIP/Postal Code
91007
Country
United States
Facility Name
Sall Research Medical Center
City
Artesia
State/Province
California
ZIP/Postal Code
90701
Country
United States
Facility Name
WCCT Global, LLC
City
Cypress
State/Province
California
ZIP/Postal Code
90630
Country
United States
Facility Name
Specialty Eye Care Medical Center
City
Glendale
State/Province
California
ZIP/Postal Code
91203
Country
United States
Facility Name
Lugene Eye Institute
City
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
Facility Name
The Eye Research Foundation
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Stanford Eye and Laser Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94303
Country
United States
Facility Name
Wolstan and Golberg Eye Associates
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
MedEye Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Central Florida Eye Institute
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
Center for Sight
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Clayton Eye Center
City
Morrow
State/Province
Georgia
ZIP/Postal Code
30260
Country
United States
Facility Name
Silverstein Eye Centers
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40206
Country
United States
Facility Name
The Eye Care Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40206
Country
United States
Facility Name
Specialized Eye Care
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21210
Country
United States
Facility Name
James D. Branch
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27101
Country
United States
Facility Name
Devers Eye Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Scott & Christie and Associates, PC
City
Cranberry Township
State/Province
Pennsylvania
ZIP/Postal Code
16066
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Total Eye Care, PA
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Cataract and Glaucoma Center
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
R and R Eye Research, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Medical Center Ophthalmology Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Hoopes Durrie Rivera Research, LLC
City
Draper
State/Province
Utah
ZIP/Postal Code
84020
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34855038
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.
Results Reference
derived
PubMed Identifier
34643894
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.
Results Reference
derived

Learn more about this trial

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

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