Phase 2
N=163
A Study of the Concurrent Use of AGN-190584 and AGN-199201 in Participants With Presbyopia
Presbyopia
Bottom Line
View on ClinicalTrials.gov: NCT02595528 ↗Enrolled (actual)
163
Serious AEs
1.9%
Results posted
Dec 2020
Primary outcome: Primary: Weighted Average Change From Baseline in Mesopic, High Contrast Uncorrected Near Visual Acuity (UNVA) Letters — 1.12; 3.83; 5.26; 5.42 letters correctly read — p=0.0029
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AGN-199201 ophthalmic solution (Drug); AGN-190584 ophthalmic solution (Drug); AGN-190584 vehicle (Drug); AGN-199201 + AGN-190584 Combination (Drug); AGN-199201 vehicle (Drug)
- Age
- Adult · 40+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Weighted Average Change From Baseline in Mesopic, High Contrast Uncorrected Near Visual Acuity (UNVA) Letters |
1.12; 3.83; 5.26; 5.42; 1.24; 3.94 | 0.0029 sig |
Summary
This study will identify the optimum concentrations of AGN-199201 and AGN-190584 when dosed in combination once a day for the improvement of uncorrected near visual acuity in participants with presbyopia (inability to focus on items close-up).
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.
Data sourced from ClinicalTrials.gov (NCT02595528). 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.