Clinical Validation Study of Comfilcon A Multifocal Toric Contact Lenses

CooperVision

Status: Completed

Conditions: Presbyopia

Treatments: Device: Omafilcon B lens (control); Device: Comfilcon A lens (test)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03417557

CV-18-10

Details and patient eligibility

About

This is a study to evaluate the clinical performance and subjective acceptance of an investigational contact lens (test), compared to a marketed lens (control) in an in-office setting.

Full description

This is a study to evaluate the clinical performance (including visual acuity, subjective assessments of visual performance, comfort ratings, vision preference and lens fit) of a comfilcon A investigational contact lens (test) compared to a control contact lens, in a non-dispensing setting. The main study hypothesis is the test contact lens will not be clinically inferior to the control lens.

Enrollment: 20 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has had a self-reported oculo-visual examination in the last two years.
• Is between ages 40-75 years, inclusive and has full legal capacity to volunteer.
• Has read and understood the information consent letter. Is willing and able to follow instructions and maintain the appointment schedule.
• Is able to participate in Parts A and B related to this work.
• Has a contact lens spherical prescription between +10.00 to 10.00D (inclusive).
• Has an Add component to their spectacle refraction (between +0.75 and +2.50DS).
• Has astigmatism between of -0.75 and -5.75DC (based on the calculated ocular refraction) in each eye.
• Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/25 best-corrected.
• Currently wears soft contact lenses.
• Has clear corneas and no active ocular disease.
• Has not worn lenses for at least 12 hours before the examination.

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 severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
• Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
• Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
• Is aphakic.
• 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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20 participants in 2 patient groups

Comfilcon A lens (test)

Experimental group

Description:

Subjects are randomized to wear comfilcon A lens for up to 3 hours, either as first or second lens during this cross over study.

Treatment:

Device: Comfilcon A lens (test)

Omafilcon B Lens (control)

Active Comparator group

Description:

Subjects are randomized to wear omafilcon B lens for up to 3 hours, either as first or second lens during this cross over study.

Treatment:

Device: Omafilcon B lens (control)