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

Allergan151 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

151

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 of AGN-190584 ophthalmic solution Doses A, B, C in the eye.

AGN-199201 VehicleDRUG

Vehicle to AGN-199201

Eligibility

Sex: ALLMin age: 40 YearsMax age: 55 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 (25)

Retina Institute of California Medical Group

Arcadia, California, United States

Outcomes

Primary Outcomes

Weighted Average Change From Baseline in Uncorrected Near Visual Acuity (UNVA) Letters in the Nondominant Eye

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, Day 28

Secondary Outcomes

Number of Participants Experiencing One or More Treatment Emergent Adverse Events (TEAEs)

A Treatment Emergent Adverse Event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. An Adverse Drug Reaction was a harmful and unintended reaction that is incurred during routine administration or use of the drug, whose causal relationship with the drug cannot be excluded.

Time frame: up to 65 days

Data from ClinicalTrials.gov

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