Back to resultsSafety and Efficacy 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
AGN-190584
AGN-199201 Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Presbyopia
Eligibility Criteria
Inclusion Criteria:
-Presbyopia in each eye that impacts daily activities.
Exclusion Criteria:
- Use of any topical ophthalmic medications, including artificial tears
- Contact lens use in either eye within 14 days or planned use during the study
- History of eye surgery
- Diagnosis of any type of glaucoma or ocular hypertension
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
AGN-199201
AGN-190584
AGN-199201 + AGN-190584 in One Eye
AGN-199201 + AGN-190584 in Both Eyes
Arm Description
1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
1 drop of AGN-190584 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in both eyes, once and twice daily for 3 days each.
Outcomes
Primary Outcome Measures
Percentage of Participants With at Least a 2 Line Improvement From Baseline in Uncorrected Near Visual Acuity (UNVA) in the Non-Dominant 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. The percentages of patients with at least a 2 or more line improvement in UNVA in the non-dominant eye are presented.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02197806
Brief Title
Safety and Efficacy of AGN-199201 and AGN-190584 in Patients With Presbyopia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A study to evaluate the safety and efficacy of AGN-199201 alone, AGN-190584 alone and concurrent use of AGN-199201 and AGN-190584 in patients with presbyopia (inability to focus for near vision).
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AGN-199201
Arm Type
Experimental
Arm Description
1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
Arm Title
AGN-190584
Arm Type
Experimental
Arm Description
1 drop of AGN-190584 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
Arm Title
AGN-199201 + AGN-190584 in One Eye
Arm Type
Experimental
Arm Description
1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
Arm Title
AGN-199201 + AGN-190584 in Both Eyes
Arm Type
Experimental
Arm Description
1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in both eyes, once and twice daily for 3 days each.
Intervention Type
Drug
Intervention Name(s)
AGN-199201
Intervention Description
1 to 2 drops of AGN-199201 ophthalmic solution in the eye(s) as per protocol.
Intervention Type
Drug
Intervention Name(s)
AGN-190584
Intervention Description
1 to 2 drops of AGN-190584 ophthalmic solution in the eye(s) as per protocol.
Intervention Type
Drug
Intervention Name(s)
AGN-199201 Vehicle
Intervention Description
1 to 2 drops of AGN-199201 vehicle in the eye(s) as per protocol.
Primary Outcome Measure Information:
Title
Percentage of Participants With at Least a 2 Line Improvement From Baseline in Uncorrected Near Visual Acuity (UNVA) in the Non-Dominant 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. The percentages of patients with at least a 2 or more line improvement in UNVA in the non-dominant eye are presented.
Time Frame
Baseline, Day 3
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:
-Presbyopia in each eye that impacts daily activities.
Exclusion Criteria:
Use of any topical ophthalmic medications, including artificial tears
Contact lens use in either eye within 14 days or planned use during the study
History of eye surgery
Diagnosis of any type of glaucoma or ocular hypertension
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Newport Beach
State/Province
California
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of AGN-199201 and AGN-190584 in Patients With Presbyopia
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