Comparison of Somofilcon A Daily Disposable Test Contact Lens and Somofilcon A Daily Disposable Control Contact Lens

CooperVision

Status

Completed

Conditions

Myopia

Treatments

Device: somofilcon A 1 day control lens

Device: somofilcon A 1 day test lens

Study type

Interventional

Funder types

Industry

Identifiers

NCT03372551

CV-16-43

Details and patient eligibility

About

The purpose of this study is to investigate the overall clinical performance of the somofilcon A daily disposable test soft contact lens compared to the somofilcon A daily disposable control soft contact lens.

Full description

The purpose of this study is to evaluate the clinical performance of an investigational silicone-hydrogel contact lens (test) against a marketed silicone-hydrogel contact lens (control) when worn on a daily disposable wear modality over 1 week (for each lens) in a randomized, bilateral, cross-over, dispensing study.

Enrollment

36 patients

Sex

All

Ages

17+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Is at least 17 years of age and has full legal capacity to volunteer;
Has had a self-reported oculo-visual examination in the last two years;
Has read, understood, and signed the information consent letter;
Is willing and able to follow instructions and maintain the appointment schedule;
Has a visual acuity of 20/30 or better (in each eye) with their habitual vision correction, or 20/20 best-corrected vision (for binocular distance acuity);
Must be able to achieve 20/30 or better (in each eye) with the study lenses;
Currently wears soft contact lenses for at least 3 days per week, 8 hours each day;
Requires spectacle lens powers between -0.75 and -06.50 diopters sphere (0.25D steps);
Has no more than 0.75 diopters of refractive astigmatism;
Has clear corneas and no active* ocular disease;
Has not worn lenses for at least 12 hours before the examination.

Exclusion criteria

Is presently participating in any other clinical or research study including eye related clinical or research study;
Has never worn contact lenses before.
Has any systemic disease affecting ocular health.
Has any active* ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
Is using any systemic or topical medications that will affect a study outcome variable, and/or ocular health.
Has any known sensitivity to fluorescein dye or products to be used in the study.
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).