A Study of the Concurrent Use of AGN-190584 and AGN-199201 in Participants With Presbyopia

Allergan163 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

163

Conditions

Presbyopia

Interventions

AGN-199201 ophthalmic solutionDRUG

1 drop of AGN-199201 ophthalmic solution Doses A, B, C in the eye.

AGN-190584 ophthalmic solutionDRUG

1 drop AGN-190584 ophthalmic solution doses A, B and C in the eye.

AGN-190584 vehicleDRUG

Vehicle to AGN-190584

Eligibility

Sex: ALLMin age: 40 YearsMax age: 50 Years

Medical Language ↔ Plain English

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.

Locations (20)

Sall Research Medical Center

Artesia, California, United States

Milton M. Hom, OD, FAAO

Outcomes

Primary Outcomes

Weighted Average Change From Baseline in Mesopic, High Contrast Uncorrected Near Visual Acuity (UNVA) Letters

UNVA is assessed without corrective lenses in the non-dominant eye. UNVA is measured using an eye chart and is reported as the number of lines read correctly. The lower the number of lines read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of lines read correctly means that vision has improved.

Time frame: Baseline, Between hour 1 and hour 10 of each of the five 2-day dosing periods

Data from ClinicalTrials.gov

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