A Safety, Efficacy and Pharmacokinetic Study of AGN-199201 and AGN-190584 in Patients With Presbyopia
- Conditions
- Presbyopia
- Interventions
- Drug: AGN-199201 VehicleDrug: AGN-199201 ophthalmic solutionDrug: AGN-190584 ophthalmic solutionDrug: AGN-190584 Vehicle
- Registration Number
- NCT02780115
- Lead Sponsor
- Allergan
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 151
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 2: AGN-199201 Dose A and AGN-190584 Dose A AGN-190584 ophthalmic solution 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. Cohort 1: Vehicle Control AGN-199201 Vehicle Vehicle dosed in both eyes administered once daily during office visits 1 through 5. Cohort 3: AGN-199201 Dose B and AGN-190584 Dose B AGN-199201 ophthalmic solution 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. Cohort 3: AGN-199201 Dose B and AGN-190584 Dose B AGN-190584 ophthalmic solution 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. Cohort 4: AGN-199201 Dose C and AGN-190584 Dose C AGN-199201 ophthalmic solution 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. Cohort 5: Vehicle, AGN-199201 Dose C and AGN-190584 Dose C AGN-199201 ophthalmic solution 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. Cohort 1: Vehicle Control AGN-190584 Vehicle Vehicle dosed in both eyes administered once daily during office visits 1 through 5. Cohort 4: AGN-199201 Dose C and AGN-190584 Dose C AGN-190584 ophthalmic solution 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. Cohort 5: Vehicle, AGN-199201 Dose C and AGN-190584 Dose C AGN-199201 Vehicle 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. Cohort 2: AGN-199201 Dose A and AGN-190584 Dose A AGN-199201 ophthalmic solution 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. Cohort 5: Vehicle, AGN-199201 Dose C and AGN-190584 Dose C AGN-190584 ophthalmic solution 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. Cohort 5: Vehicle, AGN-199201 Dose C and AGN-190584 Dose C AGN-190584 Vehicle 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.
- Primary Outcome Measures
Name Time Method Weighted Average Change From Baseline in Uncorrected Near Visual Acuity (UNVA) Letters in the Nondominant Eye 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.
- Secondary Outcome Measures
Name Time Method Number of Participants Experiencing One or More Treatment Emergent Adverse Events (TEAEs) 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.
Trial Locations
- Locations (25)
Sall Research Medical Center
🇺🇸Artesia, California, United States
Wolstan and Golberg Eye Associates
🇺🇸Torrance, California, United States
MedEye Associates
🇺🇸Miami, Florida, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
Stanford Eye and Laser Center
🇺🇸Palo Alto, California, United States
Clayton Eye Center
🇺🇸Morrow, Georgia, United States
Center for Sight
🇺🇸Sarasota, Florida, United States
Scott & Christie and Associates, PC
🇺🇸Cranberry Township, Pennsylvania, United States
Total Eye Care, PA
🇺🇸Memphis, Tennessee, United States
Hoopes Durrie Rivera Research, LLC
🇺🇸Draper, Utah, United States
R and R Eye Research, LLC
🇺🇸San Antonio, Texas, United States
Medical Center Ophthalmology Associates
🇺🇸San Antonio, Texas, United States
Retina Institute of California Medical Group
🇺🇸Arcadia, California, United States
Devers Eye Institute
🇺🇸Portland, Oregon, United States
WCCT Global, LLC
🇺🇸Cypress, California, United States
Lugene Eye Institute
🇺🇸Glendale, California, United States
Central Florida Eye Institute
🇺🇸Ocala, Florida, United States
Specialized Eye Care
🇺🇸Baltimore, Maryland, United States
Specialty Eye Care Medical Center
🇺🇸Glendale, California, United States
The Eye Research Foundation
🇺🇸Newport Beach, California, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Silverstein Eye Centers
🇺🇸Louisville, Kentucky, United States
The Eye Care Institute
🇺🇸Louisville, Kentucky, United States
James D. Branch
🇺🇸Winston-Salem, North Carolina, United States
Cataract and Glaucoma Center
🇺🇸El Paso, Texas, United States