Phase 2
N=151
A Safety, Efficacy and Pharmacokinetic Study of AGN-199201 and AGN-190584 in Patients With Presbyopia
Presbyopia
Bottom Line
View on ClinicalTrials.gov: NCT02780115 ↗Enrolled (actual)
151
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Weighted Average Change From Baseline in Uncorrected Near Visual Acuity (UNVA) Letters in the Nondominant Eye — 3.00; 4.96; 7.77; 7.54 letters correctly read — p=0.1663
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AGN-199201 ophthalmic solution (Drug); AGN-190584 ophthalmic solution (Drug); AGN-199201 Vehicle (Drug); AGN-190584 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 Uncorrected Near Visual Acuity (UNVA) Letters in the Nondominant Eye |
3.00; 4.96; 7.77; 7.54; 7.81 | 0.1663 |
| SECONDARY Number of Participants Experiencing One or More Treatment Emergent Adverse Events (TEAEs) |
8; 12; 15; 15; 10 | — |
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).
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 (NCT02780115). 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.