A Safety, Efficacy and Pharmacokinetic Study of AGN-199201 and AGN-190584 in Patients With Presbyopia

Trial ID or NCT#

NCT02780115

Status

recruiting iconRECRUITING

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

Eligibility Criteria

Ages Eligible for Study: 40 Years to 55 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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.

Investigator(s)

Edward Manche, MD
Edward Manche, MD
Ophthalmologist
Professor of Ophthalmology