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
Overview
- Phase
- Phase 2
- Intervention
- AGN-199201 Vehicle
- Conditions
- Presbyopia
- Sponsor
- Allergan
- Enrollment
- 151
- Locations
- 25
- Primary Endpoint
- Weighted Average Change From Baseline in Uncorrected Near Visual Acuity (UNVA) Letters in the Nondominant Eye
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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).
Investigators
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.
Arms & Interventions
Cohort 1: Vehicle Control
Vehicle dosed in both eyes administered once daily during office visits 1 through 5.
Intervention: AGN-199201 Vehicle
Cohort 1: Vehicle Control
Vehicle dosed in both eyes administered once daily during office visits 1 through 5.
Intervention: AGN-190584 Vehicle
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.
Intervention: AGN-199201 ophthalmic solution
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.
Intervention: AGN-190584 ophthalmic solution
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.
Intervention: AGN-199201 ophthalmic solution
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.
Intervention: AGN-190584 ophthalmic solution
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.
Intervention: AGN-199201 ophthalmic solution
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.
Intervention: AGN-190584 ophthalmic solution
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.
Intervention: AGN-199201 ophthalmic solution
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.
Intervention: AGN-190584 ophthalmic solution
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.
Intervention: AGN-199201 Vehicle
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.
Intervention: AGN-190584 Vehicle
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Number of Participants Experiencing One or More Treatment Emergent Adverse Events (TEAEs)(up to 65 days)