Safety and Efficacy of AGN-199201 and AGN-190584 in Patients With Presbyopia
1 other identifier
interventional
65
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2014
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 21, 2014
CompletedFirst Posted
Study publicly available on registry
July 23, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedResults Posted
Study results publicly available
December 3, 2015
CompletedDecember 3, 2015
October 1, 2015
3 months
July 21, 2014
October 30, 2015
October 30, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Baseline, Day 3
Study Arms (4)
AGN-199201
EXPERIMENTAL1 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.
AGN-190584
EXPERIMENTAL1 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.
AGN-199201 + AGN-190584 in One Eye
EXPERIMENTAL1 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.
AGN-199201 + AGN-190584 in Both Eyes
EXPERIMENTAL1 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.
Interventions
1 to 2 drops of AGN-199201 ophthalmic solution in the eye(s) as per protocol.
1 to 2 drops of AGN-190584 ophthalmic solution in the eye(s) as per protocol.
1 to 2 drops of AGN-199201 vehicle in the eye(s) as per protocol.
Eligibility Criteria
You may qualify if:
- Presbyopia in each eye that impacts daily activities.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (1)
Unknown Facility
Newport Beach, California, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head,
- Organization
- Allergan, Inc
Study Officials
- STUDY DIRECTOR
Medical Director
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
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2014
First Posted
July 23, 2014
Study Start
July 1, 2014
Primary Completion
October 1, 2014
Study Completion
November 1, 2014
Last Updated
December 3, 2015
Results First Posted
December 3, 2015
Record last verified: 2015-10