Phase 2
N=65
Safety and Efficacy of AGN-199201 and AGN-190584 in Patients With Presbyopia
Presbyopia
Bottom Line
View on ClinicalTrials.gov: NCT02197806 ↗Enrolled (actual)
65
Serious AEs
0.0%
Results posted
Dec 2015
Primary outcome: Primary: Percentage of Participants With at Least a 2 Line Improvement From Baseline in Uncorrected Near Visual Acuity (UNVA) in the Non-Dominant Eye — 46.7; 70.6; 56.3; 68.8 Percentage of Patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AGN-199201 (Drug); AGN-190584 (Drug); AGN-199201 Vehicle (Drug)
- Age
- Adult · 40+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With at Least a 2 Line Improvement From Baseline in Uncorrected Near Visual Acuity (UNVA) in the Non-Dominant Eye |
46.7; 70.6; 56.3; 68.8 | — |
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).
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
Data sourced from ClinicalTrials.gov (NCT02197806). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.