A Dispensing Clinical Trial of Comfilcon A Extended Range Multifocal Lenses

CooperVision

Status: Completed

Conditions: Presbyopia

Treatments: Device: comfilcon A control lens; Device: comfilcon A Extended Range test lens

Study type: Interventional

Funder types: Industry

Identifiers

NCT02719366

CV-16-07

Details and patient eligibility

About

The aim of this study is to validate the clinical of comfilcon A extended range high add center near (CN) multifocal lenses in existing contact lens wearers against the current comfilcon A high add multifocal lenses.

Full description

This study is a 20-subject, randomized, prospective, single site, daily wear, single-masked (to the subject), bilateral, 4-day cross-over, dispensing study comparing the comfilcon A extended range multifocal test lens against the comfilcon A multifocal control lens.

Enrollment: 12 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

A person is eligible for inclusion in the study if he/she:

• Has had a self-reported oculo-visual examination in the last two years
• Is 50 years of age or greater and has full legal capacity to volunteer
• Is able to read and understand the informed consent
• Is willing and able to follow instructions and maintain the appointment schedule
• Has a spherical distance contact lens prescription between -1.00 and -5.00D (Diopters) (inclusive)
• Near Add Power requirement of +2.25D or greater
• Has spectacle cylinder 0.75 D in both eyes
• Has normal binocularity (no amblyopia, no strabismus, no habitually uncorrected anisometropia ≥ 2.00D)
• Has monocular best-corrected distance visual acuity of 20/30 or better in each eye
• Has clear corneas and no active ocular disease
• Has not worn gas permeable contact lenses for 1 month prior to the study

Exclusion criteria

A person will be excluded from the study if he/she:

• Has never worn contact lenses before
• Has any systemic disease affecting ocular health
• Is using any systemic or topical medications that will affect ocular health
• Has any ocular pathology or abnormality that would affect the wearing of contact lenses
• Is aphakic (i.e. missing their natural lens inside their eye)
• Has uncorrected anisometropia (i.e. difference in the prescription between the eyes) of ≥2.00 D
• Has undergone corneal refractive surgery
• Is participating in any other type of eye related clinical or research study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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12 participants in 2 patient groups

comfilcon A Extended Range test lens

Experimental group

Description:

Subjects will be randomized to wear either the test or control pair of lens, then cross over to the alternate pair.

Treatment:

Device: comfilcon A control lens

Device: comfilcon A Extended Range test lens

comfilcon A control lens

Active Comparator group

Description:

Subjects will be randomized to wear either the test or control pair of lens, then cross over to the alternate pair.

Treatment:

Device: comfilcon A control lens

Device: comfilcon A Extended Range test lens