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

Recruiting

Trial ID: NCT02780115

Age - 40 Years-55 Years Gender - All Accepting Healthy Volunteers - No

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
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.

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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

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