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A Safety, Efficacy and Pharmacokinetic Study of AGN-199201 and AGN-190584 in Patients With Presbyopia
Recruiting
Trial ID: NCT02780115
Purpose
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).
Official Title
A Phase 2, Multicenter, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety, Efficacy, and Pharmacokinetics of the Fixed Combination of AGN-199201 and AGN-190584 in Patients With Presbyopia
Stanford Investigator(s)
Edward Manche, MD
Professor of Ophthalmology
Eligibility
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.
Intervention(s):
drug: AGN-199201 ophthalmic solution
drug: AGN-190584 ophthalmic solution
drug: AGN-199201 Vehicle
drug: AGN-190584 Vehicle
Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305