Daily Disposable Dispensing Clinical Trial of Test Lens Against Stenfilcon A Lens

CooperVision

Status

Completed

Conditions

Myopia

Treatments

Device: stenfilcon A lens (control)

Device: stenfilcon A lens with solution additive (test)

Study type

Interventional

Funder types

Industry

Identifiers

NCT03024970

CV-16-60

Details and patient eligibility

About

The purpose of this study is to investigate the overall clinical performance of the test daily disposable stenfilcon A lens with solution additive (test) compared to the stenfilcon A lens (control).

Full description

This will be, prospective, multicenter, double-masked, randomized, bilateral, 1 month cross-over, dispensing study comparing the test lens against the stenfilcon A control lens with a study duration of approximately two months.

Each subject will be randomized to wear either the test or control as a matched pair first and subjects will be randomized based on the order in which the subject is enrolled and qualified into the study.

Enrollment

72 patients

Sex

All

Ages

18+ 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 at least 18 years of age 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 correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.
- Must achieve 20/30 or better (in each eye) with study lenses
- Requires spectacle lens powers between -0.75 and -6.50 diopters sphere (0.25D steps).
- Has no more than 0.75 diopters of refractive astigmatism.
- Currently wears soft contact lenses.
- Have 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 pregnant, lactating, or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit).
- Have taken part in any other contact lens or care solution clinical trial or research, within one week prior to starting this study.