A Safety, Efficacy and Pharmacokinetic Study of AGN-199201 and AGN-190584 in Patients With Presbyopia
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
1 other identifier
interventional
151
1 country
25
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2016
Shorter than P25 for phase_2
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2016
CompletedFirst Posted
Study publicly available on registry
May 23, 2016
CompletedStudy Start
First participant enrolled
May 26, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2017
CompletedResults Posted
Study results publicly available
December 22, 2020
CompletedDecember 22, 2020
November 1, 2020
1.4 years
May 19, 2016
October 16, 2020
December 1, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Baseline, Day 28
Secondary Outcomes (1)
Number of Participants Experiencing One or More Treatment Emergent Adverse Events (TEAEs)
up to 65 days
Study Arms (5)
Cohort 1: Vehicle Control
EXPERIMENTALVehicle dosed in both eyes administered once daily during office visits 1 through 5.
Cohort 2: AGN-199201 Dose A and AGN-190584 Dose A
EXPERIMENTALFixed combinations of AGN-199201 Dose A and AGN-190584 Dose A dosed in both eyes administered once daily during office visits 1 through 5.
Cohort 3: AGN-199201 Dose B and AGN-190584 Dose B
EXPERIMENTALFixed combinations of AGN-199201 Dose B and AGN-190584 Dose B dosed in both eyes administered once daily during office visits 1 through 5.
Cohort 4: AGN-199201 Dose C and AGN-190584 Dose C
EXPERIMENTALFixed combinations of AGN-199201 Dose C and AGN-190584 Dose C dosed in both eyes administered once daily during office visits 1 through 5.
Cohort 5: Vehicle, AGN-199201 Dose C and AGN-190584 Dose C
EXPERIMENTALDominant 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.
Interventions
1 drop of AGN-199201 ophthalmic solution Doses A, B, C in the eye.
1 drop of AGN-190584 ophthalmic solution Doses A, B, C in the eye.
Vehicle to AGN-199201
Vehicle to AGN-190584
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (25)
Retina Institute of California Medical Group
Arcadia, California, 91007, United States
Sall Research Medical Center
Artesia, California, 90701, United States
WCCT Global, LLC
Cypress, California, 90630, United States
Specialty Eye Care Medical Center
Glendale, California, 91203, United States
Lugene Eye Institute
Glendale, California, 91204, United States
The Eye Research Foundation
Newport Beach, California, 92663, United States
Stanford Eye and Laser Center
Palo Alto, California, 94303, United States
Wolstan and Golberg Eye Associates
Torrance, California, 90505, United States
MedEye Associates
Miami, Florida, 33143, United States
Central Florida Eye Institute
Ocala, Florida, 34474, United States
Center for Sight
Sarasota, Florida, 34239, United States
Clayton Eye Center
Morrow, Georgia, 30260, United States
Silverstein Eye Centers
Louisville, Kentucky, 40206, United States
The Eye Care Institute
Louisville, Kentucky, 40206, United States
Specialized Eye Care
Baltimore, Maryland, 21210, United States
James D. Branch
Winston-Salem, North Carolina, 27101, United States
Devers Eye Institute
Portland, Oregon, 97210, United States
Scott & Christie and Associates, PC
Cranberry Township, Pennsylvania, 16066, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Total Eye Care, PA
Memphis, Tennessee, 38119, United States
Cataract and Glaucoma Center
El Paso, Texas, 79902, United States
University of Texas Medical Branch
Galveston, Texas, 77555, United States
R and R Eye Research, LLC
San Antonio, Texas, 78229, United States
Medical Center Ophthalmology Associates
San Antonio, Texas, 78240, United States
Hoopes Durrie Rivera Research, LLC
Draper, Utah, 84020, United States
Related Publications (2)
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.
PMID: 34855038DERIVEDJohnson 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.
PMID: 34643894DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- Allergan
Study Officials
- STUDY DIRECTOR
Haixia Liu
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2016
First Posted
May 23, 2016
Study Start
May 26, 2016
Primary Completion
October 31, 2017
Study Completion
October 31, 2017
Last Updated
December 22, 2020
Results First Posted
December 22, 2020
Record last verified: 2020-11